Catalog Number

2113-0002

Brand Name

Vitagel

Version/Model Number

2113-0002

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 30, 2018

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

P050044,P050044

Product Code

LMF

Product Code Name

Agent, absorbable hemostatic, collagen based

Public Device Record Key

507e903e-0abb-4197-88b9-2ac1637dd640

Public Version Date

November 06, 2020

Public Version Number

5

DI Record Publish Date

September 24, 2014

Package DI Number

30808232000802

Quantity per Package

5

Contains DI Package

00808232000801

Package Discontinue Date

June 30, 2018

Package Status

Not in Commercial Distribution

Package Type

pack