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COPAL® knee mould Trial M US

FDA UDI

Class I (US FDA UDI)

by Heraeus Medical LLC

Identity

Trade Name
COPAL® knee mould Trial M US FDA UDI
Generic Name
Knee revision prosthesis trial FDA UDI
Device Name
COPAL® knee mould Trials are an accessory device for intraoperative determination of the correct size of spacer made from COPAL® knee moulds (Size S: 5159868, Size M: 5159869, Size L: 5159870). COPAL® knee mould Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange revision procedure due to a septic process after thorough debridement and are intended for single use. COPAL® knee mould Trials resemble the spacer made from COPAL® knee moulds in size, shape, and geometry. COPAL® knee mould Trials are easily distinguishable from COPAL® knee mould spacers due to their prominent blue color and the stamping “Do not implant”. FDA UDI
Model / Reference
M FDA UDI
Description
COPAL® knee mould Trials are an accessory device for intraoperative determination of the correct size of spacer made from COPAL® knee moulds (Size S: 5159868, Size M: 5159869, Size L: 5159870). COPAL® knee mould Trials are used for a very short period of time (few minutes) during the first stage of a two-stage exchange revision procedure due to a septic process after thorough debridement and are intended for single use. COPAL® knee mould Trials resemble the spacer made from COPAL® knee moulds in size, shape, and geometry. COPAL® knee mould Trials are easily distinguishable from COPAL® knee mould spacers due to their prominent blue color and the stamping “Do not implant”. FDA UDI

Identifiers

Catalog Number
5165923 FDA UDI
Primary DI / UDI-DI
04260102139329 FDA UDI
FDA Product Code
HWT FDA UDI
GMDN Term
Knee revision prosthesis trial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Knee revision prosthesis trial

COPAL® knee mould Trial M US by Heraeus Medical LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Knee revision prosthesis trial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Heraeus Medical LLC

Sources (1)

  • FDA UDI a27a8643-b40f-4c93-8360-fd078370971c 34 fields · synced May 30, 2026