Duns Number:086911794
Device Description: A blue flexible band of fabric material coated on one side with a pressure-sensitive adhes A blue flexible band of fabric material coated on one side with a pressure-sensitive adhesive and with an absorbent pad for easy identification.
Catalog Number
6735CAP
Brand Name
Blue Metal Detectable Adhesive Bandage 35
Version/Model Number
6735CAP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 08, 2019
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
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
34bd5882-755c-4210-8692-a70a8bbf60a7
Public Version Date
August 07, 2020
Public Version Number
3
DI Record Publish Date
July 03, 2019
Package DI Number
07310806735000
Quantity per Package
10
Contains DI Package
07310610067359
Package Discontinue Date
July 08, 2019
Package Status
Not in Commercial Distribution
Package Type
master case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 110 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |