Catalog Number

30L10/L

Brand Name

ContexGel.sleeve

Version/Model Number

30L10/L

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ISS

Product Code Name

Prosthesis, Thigh Socket, External Component

Public Device Record Key

af79d019-0d43-4763-a37d-c4a6a5583b11

Public Version Date

November 04, 2020

Public Version Number

2

DI Record Publish Date

October 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-