Duns Number:079434709
Device Description: ABD Combine Dressing, Sterile, 8x10
Catalog Number
9071-80
Brand Name
OmniTrustTM
Version/Model Number
9071-80
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"
-
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
NAD
Product Code Name
Dressing, wound, occlusive
Public Device Record Key
2eb82886-997c-47e7-a988-fc66db0577a5
Public Version Date
June 22, 2021
Public Version Number
4
DI Record Publish Date
August 27, 2019
Package DI Number
50810572006363
Quantity per Package
30
Contains DI Package
00810572006368
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |