Duns Number:809784593
Device Description: Allkare® Adhesive Remover Wipe - 100 Pack
Catalog Number
-
Brand Name
ALLKARE
Version/Model Number
037443
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KOX
Product Code Name
SOLVENT, ADHESIVE TAPE
Public Device Record Key
9599d709-1993-4831-a06f-aee25a8233b7
Public Version Date
October 06, 2022
Public Version Number
1
DI Record Publish Date
September 28, 2022
Package DI Number
10768455107602
Quantity per Package
20
Contains DI Package
00768455107605
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 116 |
| U | Unclassified | 8 |