Duns Number:072656713
Device Description: H&H Compressed Gauze, z-folded flat containing a 4.5" x 4 yds (stretched) roll of crinkle H&H Compressed Gauze, z-folded flat containing a 4.5" x 4 yds (stretched) roll of crinkle fluff cotton gauze for use in wound management.
Catalog Number
HHPF
Brand Name
H&H Flat Compressed Gauze
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
-
Product Code
NAB
Product Code Name
Gauze / Sponge,Nonresorbable For External Use
Public Device Record Key
0eced74a-c0db-4f27-a7c1-334bad653882
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
December 31, 2020
Package DI Number
10857048006528
Quantity per Package
180
Contains DI Package
00857048006521
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 |