Duns Number:086911794
Device Description: A blue flexible band of fabric material, for the fingertip, coated on one side with a pres A blue flexible band of fabric material, for the fingertip, coated on one side with a pressure-sensitive adhesive and with an absorbent pad for easy detection.
Catalog Number
6754CAP
Brand Name
Blue Metal Detectable Adhesive Bandage Fingertip Regular
Version/Model Number
6754CAP
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
a6e9f17b-91ac-40b9-8fd5-99e5a37836d4
Public Version Date
August 07, 2020
Public Version Number
3
DI Record Publish Date
July 03, 2019
Package DI Number
07310806754001
Quantity per Package
10
Contains DI Package
07310610067540
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 |