Duns Number:072656713
Device Description: The bundle combines gauze for wound packing and wrapping with our smallest compression ban The bundle combines gauze for wound packing and wrapping with our smallest compression bandage. It fits in your pack easily and is the perfect combination for on-the-go trauma response. Mini 2x - Gauze + Compression from H&H Med Corp includes: (1) Mini Compression Bandage (1) MiniTAC Wound Gauze. Single-Use. Sterile.
Catalog Number
HHM2X
Brand Name
H&H Mini 2X Bandage/Gauze Combo Pack
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MHW
Product Code Name
Dressing, Compression
Public Device Record Key
66ce55aa-1cc9-4c27-9cb1-a9460b6f9ed9
Public Version Date
December 08, 2021
Public Version Number
2
DI Record Publish Date
March 17, 2021
Package DI Number
00857048006590
Quantity per Package
100
Contains DI Package
00857048006583
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 | 28 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |