Catalog Number

-

Brand Name

Omnifix Elastic 10cm x 2m P1 C64

Version/Model Number

9006012

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Public Device Record Key

99d507bc-f407-49d8-aad6-0c56293832f2

Public Version Date

September 09, 2020

Public Version Number

1

DI Record Publish Date

September 01, 2020

Package DI Number

04052199277301

Quantity per Package

64

Contains DI Package

04049500967754

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-