Duns Number:200564891
Device Description: Bioguard Non-Adherent Dressing, 3 in x 4 in (7.6 cm x 10.2 cm)
Catalog Number
97334
Brand Name
Bioguard Non-Adherent Dressing
Version/Model Number
97334
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NYS
Product Code Name
Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)
Public Device Record Key
01e0375d-ea47-4261-b4db-9816364b65d1
Public Version Date
May 06, 2020
Public Version Number
4
DI Record Publish Date
September 22, 2016
Package DI Number
00809958088128
Quantity per Package
18
Contains DI Package
00809958015513
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
folding box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 254 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |
| U | Unclassified | 42 |