COPAL® exchange G - The COPAL® exchange G Hip and Knee Spacers - Heraeus Medical GmbH

Duns Number:333623937

Device Description: The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stag

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More Product Details

Catalog Number

5034792

Brand Name

COPAL® exchange G

Version/Model Number

hip S long

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K191016,K191016,K191016

Product Code Details

Product Code

KWL

Product Code Name

Prosthesis, Hip, Hemi-, Femoral, Metal

Device Record Status

Public Device Record Key

a2149353-0f85-481f-b317-8e251d63088e

Public Version Date

December 03, 2019

Public Version Number

1

DI Record Publish Date

November 25, 2019

Additional Identifiers

Package DI Number

04260102136694

Quantity per Package

144

Contains DI Package

04260102136670

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pallet

"HERAEUS MEDICAL GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 4