Duns Number:176528040
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 metal detection.
Catalog Number
63088BMD
Brand Name
Green Guard Blue Metal Large Fingertip Bandage
Version/Model Number
63088BMD
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
39a0c8be-3367-4b55-bb77-438097bec2d3
Public Version Date
August 07, 2020
Public Version Number
3
DI Record Publish Date
June 26, 2019
Package DI Number
50347682630893
Quantity per Package
24
Contains DI Package
00347682630898
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 |