Duns Number:014578892
Device Description: TUBULAR GAUZE/FINGER COVERS
Catalog Number
-
Brand Name
RITE AID PHARMACY
Version/Model Number
011822210119
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)
Yes
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
77060e05-b7ea-4245-a5e9-762752d04d0d
Public Version Date
November 29, 2021
Public Version Number
1
DI Record Publish Date
November 19, 2021
Package DI Number
20011822210113
Quantity per Package
12
Contains DI Package
00011822210119
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |
| U | Unclassified | 2 |