Duns Number:007941230
Device Description: Adhesive Remover Wipe Non-sterile Contains Isopropyl Alcohol 1.15 X 2.75 Disposable/sngle Adhesive Remover Wipe Non-sterile Contains Isopropyl Alcohol 1.15 X 2.75 Disposable/sngle Use Not Nat Rubber Ltx Non Sterile MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
ARW100
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)
-
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
386c8a1d-7e21-46f8-bb03-c237ee43adf9
Public Version Date
September 29, 2020
Public Version Number
1
DI Record Publish Date
September 21, 2020
Package DI Number
30885632078839
Quantity per Package
100
Contains DI Package
10885632078835
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |