Duns Number:092364462
Device Description: Pouch: HSeal 7.5X13 Tyvek Pnk 1000/Cs
Catalog Number
-
Brand Name
Medical Action Industries
Version/Model Number
645-
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K102158,K102158,K102158
Product Code
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
6df7ae54-6959-4897-ac06-018bb5862537
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
August 20, 2016
Package DI Number
20809160004057
Quantity per Package
250
Contains DI Package
10809160004050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 548 |
2 | A medical device with a moderate to high risk that requires special controls. | 2798 |
U | Unclassified | 1 |