M2A 38MM HIP INSTRUMENTATION - Biomet Uk Ltd

Duns Number:219322575

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More Product Details

Catalog Number

31-105066

Brand Name

M2A 38MM HIP INSTRUMENTATION

Version/Model Number

31-105066

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

-

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

HWT

Product Code Name

TEMPLATE

Device Record Status

Public Device Record Key

6bae49a2-f8c8-4fbe-b0ef-b7d3aadecf4b

Public Version Date

December 21, 2020

Public Version Number

5

DI Record Publish Date

July 28, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMET UK LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 796
2 A medical device with a moderate to high risk that requires special controls. 137
3 A medical device with high risk that requires premarket approval 261