Catalog Number

2090-0036

Brand Name

Vitagel

Version/Model Number

2090-0036

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"

Yes

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

K052173,K052173

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

1b9afbfb-37ff-43bc-ac3a-2fcbebcd8557

Public Version Date

May 16, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-