Catalog Number

211254

Brand Name

Comprehensive® SRS / Discovery®

Version/Model Number

211254

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K111746,K173411

Product Code

JDC

Product Code Name

PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Public Device Record Key

bb36ad46-7497-4b80-8a30-7be6f279efc7

Public Version Date

April 02, 2021

Public Version Number

4

DI Record Publish Date

March 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-