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TPLC
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show TPLC since
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Device
indicator, physical/chemical sterilization process
Regulation Description
Sterilization process indicator.
Product Code
JOJ
Regulation Number
880.2800
Device Class
2
Premarket Reviews
Manufacturer
Decision
3M COMPANY
SUBSTANTIALLY EQUIVALENT
10
ANDERSEN STERILIZERS, INC.
SUBSTANTIALLY EQUIVALENT
2
CANADIAN TECHNICAL TAPE, LTD.
SUBSTANTIALLY EQUIVALENT
1
INTERTAPE POLYMER INC..
SUBSTANTIALLY EQUIVALENT
1
KEM MEDICAL PRODUCTS CORP.
SUBSTANTIALLY EQUIVALENT
1
SERIM RESEARCH CORPORATION
SUBSTANTIALLY EQUIVALENT
2
STERILUCENT, INC.
SUBSTANTIALLY EQUIVALENT
1
STERIS CORPORATION
SUBSTANTIALLY EQUIVALENT
10
TERRAGENE SA
SUBSTANTIALLY EQUIVALENT
1
U&U MEDICAL TECHNOLOGY CO., LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
11
11
2017
35
35
2018
12
12
2019
8
8
2020
6
6
2021
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Chemical Problem
31
31
Device Operates Differently Than Expected
31
31
Shelf Life Exceeded
6
6
Material Discolored
4
4
Improper or Incorrect Procedure or Method
3
3
Delivered as Unsterile Product
3
3
Contamination /Decontamination Problem
3
3
Device Handling Problem
3
3
Device Disinfection Or Sterilization Issue
3
3
Appropriate Term/Code Not Available
2
2
Output Problem
2
2
Test Strip
2
2
Detachment of Device or Device Component
2
2
Incorrect, Inadequate or Imprecise Resultor Readings
2
2
Expiration Date Error
2
2
Leak/Splash
2
2
Melted
1
1
Migration or Expulsion of Device
1
1
Product Quality Problem
1
1
Device Rinsing Issue
1
1
Problem with Sterilization
1
1
Device Expiration Issue
1
1
Fluid Leak
1
1
Fracture
1
1
Guidewire
1
1
Integrator
1
1
Break
1
1
Burst Container or Vessel
1
1
Device Packaging Compromised
1
1
Device Contamination with Chemical or Other Material
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Optical Discoloration
1
1
No Apparent Adverse Event
1
1
Therapeutic or Diagnostic Output Failure
1
1
Adhesive
1
1
Non Reproducible Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
28
28
No Patient Involvement
25
25
No Consequences Or Impact To Patient
11
11
No Information
3
3
No Clinical Signs, Symptoms or Conditions
2
2
Partial thickness (Second Degree) Burn
1
1
Insufficient Information
1
1
Irritation
1
1
Skin Discoloration
1
1
Foreign Body In Patient
1
1
Not Applicable
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Resource Optimization & Innovation LLC
II
Jul-24-2020
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