Duns Number:200564891
Device Description: Bioguard Island Dressing, 4 in x 5 in (10.2 cm x 12.7 cm)
Catalog Number
97045
Brand Name
Bioguard Island Dressing
Version/Model Number
97045
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
NYS
Product Code Name
Wound Dressing With Poly(Diallyl Dimethyl Ammonium Chloride)(Pdadmac)
Public Device Record Key
8a614eff-a956-49c3-bec3-1aaa9eb4e640
Public Version Date
May 06, 2020
Public Version Number
4
DI Record Publish Date
September 22, 2016
Package DI Number
00809958088319
Quantity per Package
25
Contains DI Package
00809958088302
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 |