Duns Number:804085293
Device Description: Waterproof Adhesive Tape, 1/2 IN x 10 YDS (1.27 cm x 9.1 m)
Catalog Number
-
Brand Name
Core Values
Version/Model Number
017276225419
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 10, 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"
-
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
5e47ae00-ade0-4886-b103-8d051ec5db1d
Public Version Date
May 31, 2021
Public Version Number
2
DI Record Publish Date
August 10, 2020
Package DI Number
10017276225416
Quantity per Package
72
Contains DI Package
00017276225419
Package Discontinue Date
September 17, 2019
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |