Duns Number:211352227
Device Description: Gelling Fiber Dressing
Catalog Number
BGF0245U
Brand Name
BIOSORB®
Version/Model Number
BGF0245U
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NAC
Product Code Name
Dressing, Wound, Hydrophilic
Public Device Record Key
206b1626-8623-4993-8253-896f97d05ff9
Public Version Date
July 22, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2019
Package DI Number
25051978008450
Quantity per Package
5
Contains DI Package
15051978008453
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 | 66 |
U | Unclassified | 12 |