Establishment Registration & Device Listing

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Product Code : NVY

Establishment
Name

Registration Number

Current
Registration Yr

BIOTRONIK AG

SWITZERLAND

8043892

2013

permanent defibrillator electrodes - Dextrus; Selox; Setrox S; Tilda

Contract Manufacturer; Contract Sterilizer

BIOTRONIK SE & CO. KG

GERMANY

9610139

2013

permanent defibrillator electrodes - CardioMessenger; Dextrus; Ecuro; EDP; Effecta; Estella; Evia; Evtovis; Home Monitoring; ICS 3000; Model 3145; Model 3150; Model 3171; Model 3175; Model 6646; Model 6652; Model 6653; P-KIT; PSW 1203.U/1; Reliaty; Renamic; Reocor; Selox; Setrox S; SLX; Solox; Tilda

Manufacturer

permanent defibrillator electrodes - D-KIT; D2-KIT; ICS 3000; Kainox VCS; Linox; Linoxsmart; PSW 1203.U/1; Renamic; Vigila; Volta

Manufacturer

BIOTRONIK, INC.

OR/USA

1028232

2013

permanent defibrillator electrodes - CardioMessenger; Dextrus; Ecuro; EDP; Effecta; Estella; Evia; Evtovis; Home Monitoring; ICS 3000; Model 3145; Model 3150; Model 3171; Model 3175; Model 6646; Model 6652; Model 6653; P-KIT; PSW 1203.U/1; Reliaty; Renamic; Reocor; Selox; Setrox S; Solox; Tilda

Repackager/Relabeler

permanent defibrillator electrodes - D-KIT; D2-KIT; ICS 3000; Kainox VCS; Linox; Linoxsmart; PSW 1203.U/1; Renamic; Vigila; Volta

Repackager/Relabeler

Boston Scientific Corporation

PR/USA

2648729

2013

permanent defibrillator electrodes - ACUITY STEERABLE

Manufacturer

permanent defibrillator electrodes - Fixation Tool; FLEXTEND; SWEET PICOTIP Rx; SWEET TIP Rx

Manufacturer

permanent defibrillator electrodes - 4-Site Lead Pulling Tip, 4-SITE; 4-SITE Terminal Tool; Bipolar Positive Fixation lead & adapter; combined models 6017 & 4266; ENDOTAK C; ENDOTAK DSP; ENDOTAK ENDURANCE; ENDOTAK ENDURANCE EZ; ENDOTAK ENDURANCE Rx; ENDOTAK RELIANCE; ENDOTAK RELIANCE 4-Site Active; ENDOTAK RELIANCE 4-Site Passive; ENDOTAK RELIANCE G ? Active; ENDOTAK RELIANCE G ? Passive; ENDOTAK RELIANCE G 4-Site Active; ENDOTAK RELIANCE G 4-Site Passive; ENDOTAK RELIANCE S; ENDOTAK RELIANCE S 4-Site Active; ENDOTAK RELIANCE S 4-Site Passive; ENDOTAK RELIANCE SG ? Active; ENDOTAK RELIANCE SG ? Passive; ENDOTAK RELIANCE SG 4-Site Active; ENDOTAK RELIANCE SG 4-Site Passive; ENDOTAK SQ Array; ENDOTAK SQ Array XP; ENDOTAK SQ Patch Lead; Lead Adapter; Lead Cap Accessory Kit; Lead Cap Kit; Lead Tunneler Kit; Lead Tunneling Tip; Stylet

Manufacturer

permanent defibrillator electrodes - Atrial J SELUTE PICOTIP; SELUTE Bipolar; SELUTE PICOTIP; SELUTE Unipolar; Straight Stylet

Manufacturer

permanent defibrillator electrodes - FINELINE; FINELINE II; FINELINE II EZ; FINELINE II Sterox; FINELINE II Sterox EZ; Straight Stylet; Stylet, Atrial Medium ?J?; Stylet, Large Atrial ?J? Tapered; Stylet, Straight Tapered; Suture Sleeve Accessory Pack; Tapered Stylet; ThinLine; ThinLine EZ; ThinLine II; ThinLine II EZ; ThinLine II Sterox; ThinLine II Sterox EZ

Manufacturer

Boston Scientific Corporation

MN/USA

2124215

2013

permanent defibrillator electrodes - ACUITY STEERABLE

Specification Developer

permanent defibrillator electrodes - Fixation Tool; FLEXTEND; SWEET PICOTIP Rx; SWEET TIP Rx

Specification Developer

permanent defibrillator electrodes - 4-Site Lead Pulling Tip, 4-SITE; 4-SITE Terminal Tool; Bipolar Positive Fixation lead & adapter; combined models 6017 & 4266; ENDOTAK C; ENDOTAK DSP; ENDOTAK ENDURANCE; ENDOTAK ENDURANCE EZ; ENDOTAK ENDURANCE Rx; ENDOTAK RELIANCE; ENDOTAK RELIANCE 4-Site Active; ENDOTAK RELIANCE 4-Site Passive; ENDOTAK RELIANCE G ? Active; ENDOTAK RELIANCE G ? Passive; ENDOTAK RELIANCE G 4-Site Active; ENDOTAK RELIANCE G 4-Site Passive; ENDOTAK RELIANCE S; ENDOTAK RELIANCE S 4-Site Active; ENDOTAK RELIANCE S 4-Site Passive; ENDOTAK RELIANCE SG ? Active; ENDOTAK RELIANCE SG ? Passive; ENDOTAK RELIANCE SG 4-Site Active; ENDOTAK RELIANCE SG 4-Site Passive; ENDOTAK SQ Array; ENDOTAK SQ Array XP; ENDOTAK SQ Patch Lead; Lead Adapter; Lead Cap Accessory Kit; Lead Cap Kit; Lead Tunneler Kit; Lead Tunneling Tip; Stylet

Manufacturer

permanent defibrillator electrodes - Atrial J SELUTE PICOTIP; SELUTE Bipolar; SELUTE PICOTIP; SELUTE Unipolar; Straight Stylet

Manufacturer

permanent defibrillator electrodes - FINELINE; FINELINE II; FINELINE II EZ; FINELINE II Sterox; FINELINE II Sterox EZ; Straight Stylet; Stylet, Atrial Medium ?J?; Stylet, Large Atrial ?J? Tapered; Stylet, Straight Tapered; Suture Sleeve Accessory Pack; Tapered Stylet; ThinLine; ThinLine EZ; ThinLine II; ThinLine II EZ; ThinLine II Sterox; ThinLine II Sterox EZ

Manufacturer

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Establishment Registration & Device Listing

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