Duns Number:080240553
Device Description: OneStop™ Bandage is indicated for the local management of bleeding wounds such as minor cu OneStop™ Bandage is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations and minor abrasions and in patients on anticoagulationtherapy. It also provides an antibacterial barrier against a wide range of gram positive and gram negative organisms.
Catalog Number
1112
Brand Name
HemCon® OneStop™ Bandage, 2in x 2in, OTC
Version/Model Number
1
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150916,K150916
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
fb19ad8e-c9fd-49f4-b920-8cce715208c0
Public Version Date
May 13, 2021
Public Version Number
1
DI Record Publish Date
May 05, 2021
Package DI Number
50870053000365
Quantity per Package
50
Contains DI Package
00870053000360
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| U | Unclassified | 6 |