COPAL® exchange G - COPAL® exchange G hip spacers provide patients, - Heraeus Medical GmbH

Duns Number:333623937

Device Description: COPAL® exchange G hip spacers provide patients, undergoing a two-stage revision procedure

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More Product Details

Catalog Number

5147215

Brand Name

COPAL® exchange G

Version/Model Number

hip S medium

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

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KWL

Product Code Name

Prosthesis, Hip, Hemi-, Femoral, Metal

Device Record Status

Public Device Record Key

b19545a9-bc63-463f-94a6-9ed487fe2b30

Public Version Date

May 23, 2022

Public Version Number

1

DI Record Publish Date

May 15, 2022

Additional Identifiers

Package DI Number

04260102139190

Quantity per Package

144

Contains DI Package

04260102139176

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