Duns Number:152793493
Device Description: Adhesive Bandages, all one size, 3/4 IN x 3 IN (19 mm x 76 mm)
Catalog Number
GAR5293
Brand Name
Garfield
Version/Model Number
017276980233
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 11, 2021
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
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
670db6c5-75e3-4453-8dc3-1c72d0764f76
Public Version Date
August 04, 2022
Public Version Number
2
DI Record Publish Date
September 20, 2020
Package DI Number
20017276980237
Quantity per Package
12
Contains DI Package
00017276980233
Package Discontinue Date
October 11, 2021
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 | 48 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| U | Unclassified | 1 |