Duns Number:152793493
Device Description: Waterproof Adhesive Bandages, assorted sizes (3/4 in x 1 1/2 in; 3/4 in x 2 in; 1 in x 2 1 Waterproof Adhesive Bandages, assorted sizes (3/4 in x 1 1/2 in; 3/4 in x 2 in; 1 in x 2 1/2 in)
Catalog Number
017276233759
Brand Name
ALL-HEALTH Adhesive Bandages
Version/Model Number
017276233759
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 20, 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"
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
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
f721a91d-2e7b-43c4-8305-aa77ac458e78
Public Version Date
May 11, 2021
Public Version Number
4
DI Record Publish Date
March 29, 2019
Package DI Number
20017276233753
Quantity per Package
72
Contains DI Package
00017276233759
Package Discontinue Date
November 20, 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 | 48 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |
| U | Unclassified | 1 |