Duns Number:025460908
Device Description: WRAPPER,ASTAT,GORE HEM,JADE,36X36,5/DZCS
Catalog Number
MDTAUS13136
Brand Name
Medline
Version/Model Number
MDTAUS13136
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
-
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
-
Product Code
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
f80856f0-0ec6-451c-b154-4e209823fd9f
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
October 14, 2016
Package DI Number
30888277417902
Quantity per Package
5
Contains DI Package
20888277417905
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |