Duns Number:023904428
Device Description: Dressing Retention Tape 2” PRINTED CUT LINES Released Backing 6 in. x 10 yds.
Catalog Number
-
Brand Name
McKesson
Version/Model Number
4811
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
7bee55be-d539-451c-8cff-c700689908f0
Public Version Date
December 08, 2021
Public Version Number
3
DI Record Publish Date
May 27, 2020
Package DI Number
00612479203525
Quantity per Package
12
Contains DI Package
00612479203518
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |