Duns Number:007924756
Device Description: Antibacterial Gauze Pads, 2 pads per wrapper, 2 IN x 2 IN (50 mm x 50 mm)
Catalog Number
-
Brand Name
H-E-B
Version/Model Number
041220048632
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
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
203ed464-2cea-4eb4-9720-d7b63cb0b77e
Public Version Date
August 04, 2020
Public Version Number
1
DI Record Publish Date
July 27, 2020
Package DI Number
20041220048636
Quantity per Package
72
Contains DI Package
00041220048632
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |