Duns Number:791014871
Device Description: Sterile Antimicrobial Bandage Roll 4"x4.1yd
Catalog Number
AB100
Brand Name
Dukal
Version/Model Number
AB100
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
K181315,K181315
Product Code
FRO
Product Code Name
Dressing, wound, drug
Public Device Record Key
bce5cdb1-c5f4-455b-98ee-7db61b18fd5c
Public Version Date
May 23, 2022
Public Version Number
2
DI Record Publish Date
March 28, 2022
Package DI Number
20665973028099
Quantity per Package
100
Contains DI Package
10665973028092
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |
| U | Unclassified | 1 |