Duns Number:315731711
Device Description: Nexcare™ Durable Cloth First Aid Tape 791-1PK, 1 in x 10 yds
Catalog Number
791-1PK
Brand Name
Nexcare™
Version/Model Number
791-1PK
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)
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
32db1e7c-dfe6-490b-807c-f285ad4feb6c
Public Version Date
March 10, 2021
Public Version Number
1
DI Record Publish Date
March 02, 2021
Package DI Number
50051131223276
Quantity per Package
4
Contains DI Package
30051131223272
Package Discontinue Date
-
Package Status
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 | 232 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 563 |
| U | Unclassified | 3 |