HTR-PMI - BIOMET MICROFIXATION, INC

Duns Number:046189866

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More Product Details

Catalog Number

-

Brand Name

HTR-PMI

Version/Model Number

PM624782

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

K924935

Product Code Details

Product Code

FWP

Product Code Name

Prosthesis, Chin, Internal

Device Record Status

Public Device Record Key

ea90c75c-6daa-4544-8a60-c699eefb4574

Public Version Date

March 18, 2022

Public Version Number

1

DI Record Publish Date

March 10, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMET MICROFIXATION, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1783
2 A medical device with a moderate to high risk that requires special controls. 11874
3 A medical device with high risk that requires premarket approval 34