Duns Number:086911794
Device Description: A flexible band of fabric material coated on one side with a pressure-sensitive adhesive A flexible band of fabric material coated on one side with a pressure-sensitive adhesive and with an absorbent pad intended to cover a superficial wound on a knuckle.
Catalog Number
62730
Brand Name
Medi-First HW Flexible Knuckle Bandage
Version/Model Number
62730
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"
-
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
22989e24-4ce0-4420-893a-73f525b34b27
Public Version Date
August 07, 2020
Public Version Number
3
DI Record Publish Date
July 19, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |