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TPLC
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Device
indicator, biological sterilization process
Regulation Description
Sterilization process indicator.
Product Code
FRC
Regulation Number
880.2800
Device Class
2
Premarket Reviews
Manufacturer
Decision
3M
SUBSTANTIALLY EQUIVALENT
1
3M COMPANY
SUBSTANTIALLY EQUIVALENT
14
3M COMPLANY
SUBSTANTIALLY EQUIVALENT
1
ADVANCED STERILIZATION PRODUCTS (ASP)
SUBSTANTIALLY EQUIVALENT
1
ANDERSEN STERILIZERS, INC.
SUBSTANTIALLY EQUIVALENT
3
PLASMAPP CO,.LTD.
SUBSTANTIALLY EQUIVALENT
1
PLASMAPP CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
STERIS
SUBSTANTIALLY EQUIVALENT
1
STERIS CORPORATION
SUBSTANTIALLY EQUIVALENT
7
TERRAGENE S.A.
SUBSTANTIALLY EQUIVALENT
1
TERRAGENE SA
SUBSTANTIALLY EQUIVALENT
2
TRUE INDICATING LLC
SUBSTANTIALLY EQUIVALENT
1
TSO3 INC., NOW A PART OF STRYKER
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
16
16
2021
10
10
2022
9
9
2023
20
20
2024
22
22
Device Problems
MDRs with this Device Problem
Events in those MDRs
Appropriate Term/Code Not Available
53
53
Leak/Splash
6
6
Adverse Event Without Identified Device or Use Problem
4
4
Use of Device Problem
4
4
Contamination /Decontamination Problem
2
2
Insufficient Information
2
2
Device Reprocessing Problem
1
1
Chemical Problem
1
1
Problem with Sterilization
1
1
Component Missing
1
1
Defective Device
1
1
Therapeutic or Diagnostic Output Failure
1
1
No Apparent Adverse Event
1
1
Break
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
50
50
No Consequences Or Impact To Patient
14
14
Burn(s)
3
3
No Known Impact Or Consequence To Patient
3
3
Insufficient Information
2
2
Eye Injury
1
1
Skin Discoloration
1
1
Eye Pain
1
1
Laceration(s)
1
1
Discomfort
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
3M Company - Health Care Business
II
Sep-26-2023
2
Mckesson Medical-Surgical Inc. Corporate Office
III
Sep-26-2022
3
Steris Corporation
II
Jan-03-2023
4
TERRAGENE S.A.
II
Jan-26-2024
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