Catalog Number

88103

Brand Name

Retrax Gel FS ProPack SAMPLE

Version/Model Number

88103

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"

-

For Single-Use

-

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

MVL

Product Code Name

Cord, Retraction

Public Device Record Key

a7e549fe-0fe3-4edf-ba31-74e44388b2c4

Public Version Date

July 01, 2022

Public Version Number

1

DI Record Publish Date

June 23, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-