Duns Number:168720709
Device Description: Self-Sealing Sterilization Pouches 5.25" x 10" 200 per Box
Catalog Number
TIG-5.25X10
Brand Name
Tiger Supply Inc.
Version/Model Number
TIG-5.25X10
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
-
Product Code
KCT
Product Code Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Public Device Record Key
ba93090d-dd93-4b0e-870e-a15526f85dcd
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
D823TIG525X1015
Quantity per Package
10
Contains DI Package
D823TIG525X1004
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |