Catalog Number

557099

Brand Name

S-ROM

Version/Model Number

55-7099

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

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

K931676

Product Code

JDL

Product Code Name

Prosthesis, hip, semi-constrained (metal cemented acetabular component)

Public Device Record Key

9e78857d-b4b8-474f-87e2-b1bd42020e7a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-