Catalog Number

BG1001

Brand Name

BandGrip® Micro-Anchor® Skin Closure

Version/Model Number

BG1001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 15, 2020

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

FZQ

Product Code Name

CLIP, REMOVABLE (SKIN)

Public Device Record Key

e05b3450-2371-44a6-b288-67a3ac425d3b

Public Version Date

March 02, 2021

Public Version Number

2

DI Record Publish Date

March 24, 2020

Package DI Number

30850010207071

Quantity per Package

20

Contains DI Package

00850010207070

Package Discontinue Date

December 15, 2020

Package Status

Not in Commercial Distribution

Package Type

Case