COPAL® exchange G - COPAL® exchange G Trials are an accessory device - Heraeus Medical GmbH

Duns Number:333623937

Device Description: COPAL® exchange G Trials are an accessory device for intra-operative determination of the COPAL® exchange G Trials are an accessory device for intra-operative determination of the correct size of the COPAL® exchange G Spacer. COPAL® exchange G Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange septic revision surgery after thorough debridement and are intended for single use. COPAL® exchange G hip and knee Trials resemble the COPAL® exchange G hip and knee Spacers in size, shape and geometry. COPAL® exchange G Trials are easily distin-guishable from COPAL® exchange G Spacers due to their hollow body, their prominent blue color and the stamping “TRIAL - DO NOT IMPLANT”.COPAL® exchange G Trials are available for hip and knee. COPAL® exchange G hip Trials resemble a hemi-endopros-thesis and are available in 8 different sizes. COPAL® exchange G knee Trials consist of a femoral and tibial component and are available in 3 different sizes.COPAL® exchange G Trials do not contain gentamicin.

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More Product Details

Catalog Number

5097413

Brand Name

COPAL® exchange G

Version/Model Number

Trial Set hip M

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

-

Product Code Details

Product Code

HWT

Product Code Name

Template

Device Record Status

Public Device Record Key

87ac7dd6-22ad-4fda-8d0b-5f6e7fd6dd38

Public Version Date

July 15, 2020

Public Version Number

1

DI Record Publish Date

July 07, 2020

Additional Identifiers

Package DI Number

04260102130814

Quantity per Package

15

Contains DI Package

04260102130432

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"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