Duns Number:086911794
Device Description: A blue flexible band of fabric material, for easy detection, coated on one side with a pre A blue flexible band of fabric material, for easy detection, coated on one side with a pressure-sensitive adhesive and with an absorbent pad intended to cover a superficial wound on the knuckle.
Catalog Number
65278
Brand Name
Medi-First Blue metal Detecetable Woven Knuckle
Version/Model Number
65278
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)
-
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
a4969273-76fb-4e17-b9c7-6e183ddfccea
Public Version Date
August 07, 2020
Public Version Number
3
DI Record Publish Date
July 03, 2019
Package DI Number
50347682652789
Quantity per Package
24
Contains DI Package
00347682652784
Package Discontinue Date
-
Package Status
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 |