Catalog Number

-

Brand Name

GLUSTITCH TWIST

Version/Model Number

GLTWI05C

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 01, 2019

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K150032,K150032,K150032

Product Code

MPN

Product Code Name

Tissue Adhesive For The Topical Approximation Of Skin

Public Device Record Key

ec1cc28d-16d2-4283-b160-4befa7f420fd

Public Version Date

March 01, 2019

Public Version Number

4

DI Record Publish Date

February 13, 2017

Package DI Number

D795G000151

Quantity per Package

6

Contains DI Package

D795G000150

Package Discontinue Date

March 01, 2019

Package Status

Not in Commercial Distribution

Package Type

BOX