Duns Number:176528040
Device Description: A small, narrow, flexible band of fabric material for the knuckle coated on one side with A small, narrow, flexible band of fabric material for the knuckle coated on one side with a pressure-sensitive adhesive and with an absorbent pad.
Catalog Number
6304
Brand Name
Green Guard Knuckle Bandages
Version/Model Number
6304
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
68d5c521-8379-433f-837b-96c1cda8e08b
Public Version Date
August 07, 2020
Public Version Number
3
DI Record Publish Date
June 26, 2019
Package DI Number
50347682063042
Quantity per Package
32
Contains DI Package
00347682063047
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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |