Duns Number:200564891
Device Description: Bioguard Burn Dressing - Ready-Cut Gauze, 100 Ply - Mesh Gauze 18 in x 18 in (45.7 cm x 45 Bioguard Burn Dressing - Ready-Cut Gauze, 100 Ply - Mesh Gauze 18 in x 18 in (45.7 cm x 45.7 cm)
Catalog Number
97118
Brand Name
Bioguard Burn Dressing - Ready-Cut Gauze
Version/Model Number
97118
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
958cbabf-f7ee-4359-b0f1-26320565125e
Public Version Date
May 06, 2020
Public Version Number
4
DI Record Publish Date
January 16, 2017
Package DI Number
00809958088913
Quantity per Package
10
Contains DI Package
00809958088906
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| 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 |