ProMade - M6 Handle with Flange - LIMACORPORATE SPA

Duns Number:432066322

Device Description: M6 Handle with Flange

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More Product Details

Catalog Number

9CC0.13.03D

Brand Name

ProMade

Version/Model Number

9CC0.13.03D

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

K112158

Product Code Details

Product Code

JDI

Product Code Name

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Device Record Status

Public Device Record Key

8254e5c9-e23a-4009-a8ae-539b5d2beccd

Public Version Date

September 29, 2022

Public Version Number

1

DI Record Publish Date

September 21, 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