Duns Number:315768788
Device Description: SORBALGON 2X2 10/BX
Catalog Number
-
Brand Name
SORBALGON 2X2 10/BX
Version/Model Number
49200001
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)
-
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
309b03b4-369c-4a55-a587-427009e82cdd
Public Version Date
July 22, 2021
Public Version Number
2
DI Record Publish Date
September 01, 2020
Package DI Number
04052199569772
Quantity per Package
10
Contains DI Package
04052199569765
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 | 99 |
U | Unclassified | 1 |