Duns Number:007924756
Device Description: Gauze Pads, 3 IN x 3 IN (76 mm x 76 mm)
Catalog Number
-
Brand Name
H-E-B
Version/Model Number
041220832422
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 30, 2020
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"
-
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
86f948f5-5bce-4e15-9c18-f842bf9db351
Public Version Date
August 24, 2021
Public Version Number
3
DI Record Publish Date
July 27, 2020
Package DI Number
20041220832426
Quantity per Package
72
Contains DI Package
00041220832422
Package Discontinue Date
November 30, 2020
Package Status
Not 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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |