Duns Number:080240553
Device Description: HemCon GuardaCareXR Surgical is a hemostatic temporary surgical dressing comprised of a ch HemCon GuardaCareXR Surgical is a hemostatic temporary surgical dressing comprised of a chitosan coated polyester/rayon blend, non-woven, medical-grade gauze, and a single radio- opaque element. The dressing is z-folded and packaged in a sterile double pouch.
Catalog Number
1032
Brand Name
GuardaCare®XR Surgical, 4in x 4in, 8ply
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K103641,K103641,K103641
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
be91851d-7907-41ee-917f-be0628150827
Public Version Date
July 16, 2021
Public Version Number
1
DI Record Publish Date
July 08, 2021
Package DI Number
20870053000111
Quantity per Package
10
Contains DI Package
00870053000117
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| U | Unclassified | 6 |