AMF REVISION TT CONES - AMF Revision TT Cones - Bycondylar Femur Phantom - LIMACORPORATE SPA

Duns Number:432066322

Device Description: AMF Revision TT Cones - Bycondylar Femur Phantom Dai. 21 mm Right

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More Product Details

Catalog Number

906C.12.121

Brand Name

AMF REVISION TT CONES

Version/Model Number

906C.12.121

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

4db6226b-ec07-48a2-a035-ccc0e3c92441

Public Version Date

April 06, 2022

Public Version Number

1

DI Record Publish Date

March 29, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIMACORPORATE SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 595
2 A medical device with a moderate to high risk that requires special controls. 3634