BI-MENTUM PE Liner - BI-MENTUM dual mobility system -BI-MENTUM PE - SOC ETUDES RECHERCHES FABRICATION

Duns Number:282651413

Device Description: BI-MENTUM dual mobility system -BI-MENTUM PE Liner polyethylene liner

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More Product Details

Catalog Number

-

Brand Name

BI-MENTUM PE Liner

Version/Model Number

BI-MENTUM PE Liner 22,2 / 41

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

LZO

Product Code Name

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Device Record Status

Public Device Record Key

eb9bfbdf-4b10-41fc-9210-0c64778615a0

Public Version Date

February 15, 2019

Public Version Number

1

DI Record Publish Date

January 15, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SOC ETUDES RECHERCHES FABRICATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 206