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U.S. Department of Health and Human Services

Establishment Registration & Device Listing

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Proprietary Name: ATS Cyclindrical Cuff, Single Port/Dual Bladder; ATS Cylindrical Cuff, Dual Port/Dual Bladder; ATS Cylindrical Cuff, Dual Port/Single Bladder; ATS Cylindrical Cuff, Single Port/Single Bladder; ATS Tourniquet Systems; Basket; Dual Port, Dual Bladder, cuff with PLC and protective sleeve; Dual Port, Single Bladder cuff with PLC and protective sleeve; Dual Port/Dual Bladder Disposable Cuff; Dual Port/Single Bladder Contour Lge Thigh Cuff; Dual Port/Single Bladder Disposable Cuff; Hose with CPC connector; Hoses; IV Pole / Rollstand; Luer Adaptors; Protective sleeve for Disposable Cuff; Retrofit Kit; Single Port, Single Bladder cuff with PLC and protective sleeve; Single Port/Dual Bladder Disposable Cuff; Single Port/Dual Bladder Disposable Cuff with PLC; Single Port/Single Bladder Contour Lge Thigh Cuff; Single Port/Single Bladder Disposable Cuff; Stand Base; Tank Holder
Classification Name: TOURNIQUET, PNEUMATIC
Product Code: KCY
Device Class: 1
Regulation Number: 878.5910
Medical Specialty: General & Plastic Surgery
Registered Establishment Name: ZIMMER SURGICAL, INC.
Registered Establishment Number: 1526350
Owner/Operator: ZIMMER, INC.
Owner/Operator Number: 1822565
Establishment Operations: Manufacturer; Repackager/Relabeler; Specification Developer
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