Duns Number:095153714
Device Description: Steam Sterilization Indicator Tape
Catalog Number
PIT100-1
Brand Name
ProChek ID
Version/Model Number
PIT100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K951113,K951113
Product Code
LRT
Product Code Name
Indicator, Sterilization
Public Device Record Key
0f47492f-43fc-4cc2-ba72-2c7e468fcdae
Public Version Date
November 01, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
H816PIT1002
Quantity per Package
6
Contains DI Package
H816PIT1001
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |