Catalog Number

-

Brand Name

Gelfilm

Version/Model Number

Gelfilm® Sterile Film Sterile film 1's (125 sq cm)

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 25, 2016

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

-

Product Code

OOD

Product Code Name

surgical film

Public Device Record Key

565636c1-b397-45f1-8990-183ba206909b

Public Version Date

December 17, 2020

Public Version Number

6

DI Record Publish Date

October 22, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-