COPAL® exchange G

GUDID 04260102130807

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.

Heraeus Medical GmbH

Hip revision prosthesis trial
Primary Device ID04260102130807
NIH Device Record Keybac26d98-e4d1-4c5f-bc5a-3bc3d16286c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOPAL® exchange G
Version Model NumberTrial Set hip S
Company DUNS333623937
Company NameHeraeus Medical GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260102130241 [Primary]
GS104260102130807 [Package]
Contains: 04260102130241
Package: Carton [15 Units]
In Commercial Distribution
GS104260102131163 [Package]
Contains: 04260102130241
Package: Pallet [210 Units]
In Commercial Distribution

FDA Product Code

HWTTemplate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-15
Device Publish Date2020-07-07

On-Brand Devices [COPAL® exchange G]

04260102136991The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102136960The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102136939The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102130609COPAL® exchange G Trials are an accessory device for intra-operative determination of the corre
04260102131149COPAL® exchange G Trials are an accessory device for intra-operative determination of the corre
04260102131132COPAL® exchange G Trials are an accessory device for intra-operative determination of the corre
04260102130814COPAL® exchange G Trials are an accessory device for intra-operative determination of the corre
04260102130807COPAL® exchange G Trials are an accessory device for intra-operative determination of the corre
04260102139220COPAL® exchange G hip spacers provide patients, undergoing a two-stage revision procedure for a
04260102139190COPAL® exchange G hip spacers provide patients, undergoing a two-stage revision procedure for a
04260102136885The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102136878The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102136847The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102136816The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102136786The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102136755The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102136724The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev
04260102136694The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage rev

Trademark Results [COPAL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COPAL
COPAL
97715895 not registered Live/Pending
In Mocean Group LLC
2022-12-13
COPAL
COPAL
79225667 5663402 Live/Registered
Krzysztof Bawol
2017-08-21
COPAL
COPAL
79131038 4473176 Live/Registered
NIDEC COPAL CORPORATION
2013-04-15
COPAL
COPAL
77913448 3834767 Dead/Cancelled
Thiem, Hannah L
2010-01-16
COPAL
COPAL
77882561 not registered Dead/Abandoned
Chokron, Melanie
2009-11-30
COPAL
COPAL
77655389 not registered Dead/Abandoned
Chokron, Melanie
2009-01-23
COPAL
COPAL
76712615 4445460 Live/Registered
Heraeus Medical GmbH
2012-10-12
COPAL
COPAL
76628054 3134732 Dead/Cancelled
Heraeus Kulzer GmbH
2005-01-18
COPAL
COPAL
75642936 not registered Dead/Abandoned
Maruba Therapy, Inc.
1999-02-16
COPAL
COPAL
75416593 2228206 Dead/Cancelled
Merck KGaA, Kommanditgesellschaft auf Aktien
1998-01-12
COPAL
COPAL
75196772 not registered Dead/Abandoned
Maruba Therapy, Inc.
1996-11-12
COPAL
COPAL
74548595 1982985 Live/Registered
ADOBE INC.
1994-07-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.