Heraeus Medical GmbH

Address:PHILIPP-REIS-STRASSE 8/13,WEHRHEIM Hesse,DE

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Device Description : COPAL® exchange G Trials are an accessory device for intra-operative determinati 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.

Device Class :

Duns Number: 333623937

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5097413

Device Description : COPAL® exchange G Trials are an accessory device for intra-operative determinati 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.

Device Class :

Duns Number: 333623937

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5097414

Device Description : COPAL® exchange G Trials are an accessory device for intra-operative determinati 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.

Device Class :

Duns Number: 333623937

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

- Catalog Number : 66031896

Device Description : Osteopal® V is an acrylic cement for use in vertebroplasty and kyphoplasty. It i Osteopal® V is an acrylic cement for use in vertebroplasty and kyphoplasty. It is formed from powder and liquid by exothermic polymerization

Device Class :

Duns Number: 333623937

Premarket Exempt : No

Product Code : LOD, NDN

Prescription Use : Yes

Device Count : 1

- Catalog Number : 5097415

Device Description : COPAL® exchange G Trials are an accessory device for intra-operative determinati 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.

Device Class :

Duns Number: 333623937

Premarket Exempt : Yes

Product Code : HWT

Prescription Use : Yes

Device Count : 1

- Catalog Number : 66036163

Device Description : The PALAMIX® cement gun is intended to accommodate the mixing cartridges of the The PALAMIX® cement gun is intended to accommodate the mixing cartridges of the PALAMIX® vacuum mixing system or the PALACOS® R+G pro and then to ensure precise and effortless application of bone cement. The trigger of the PALAMIX® cement gun is operated by hand to expel the bone cement from the mixing cartridge. Activating the trigger advances the feed rod in the mixing cartridge and expels the bone cement under high pressure. The PALAMIX® cement gun can only be used in conjunction with the PALAMIX® vacuum mixing system or PALACOS® R+G pro.

Device Class : 1

Duns Number: 333623937

Premarket Exempt : Yes

Product Code : KIH

Prescription Use : Yes

Device Count : 1

- Catalog Number : 66036748

Device Description : Reusable vacuum pump with one-way valve to use together with PALAMIX for mixing Reusable vacuum pump with one-way valve to use together with PALAMIX for mixing under vacuum

Device Class : 1

Duns Number: 333623937

Premarket Exempt : Yes

Product Code : JDY

Prescription Use : Yes

Device Count : 1

- Catalog Number : 66036747

Device Description : PALAMIX® nozzles are available in different lengths and diameters for applying b PALAMIX® nozzles are available in different lengths and diameters for applying bone cement pre-mixed by the PALAMIX® uno or PALAMIX® duo vacuum mixing system. PALAMIX® nozzle slim is the accessory of PALAMIX® uno or PALAMIX® duo vacuum mixing system intended for use in placing bone cement into surgical sites.

Device Class :

Duns Number: 333623937

Premarket Exempt : Yes

Product Code : KIH

Prescription Use : Yes

Device Count : 1

- Catalog Number : 66043960

Device Description : PALAMIX® nozzles are available in different lengths and diameters for applying b PALAMIX® nozzles are available in different lengths and diameters for applying bone cement pre-mixed by the PALAMIX® uno or PALAMIX® duo vacuum mixing system. PALAMIX® nozzle medium is the accessory of PALAMIX® uno or PALAMIX® duo vacuum mixing system intended for use in placing bone cement into surgical sites.

Device Class :

Duns Number: 333623937

Premarket Exempt : Yes

Product Code : KIH

Prescription Use : Yes

Device Count : 1

- Catalog Number : 66045747

Device Description : OSTEOPAL® plus is a radiopaque, low-viscosity bonecement, based on polymethyl me OSTEOPAL® plus is a radiopaque, low-viscosity bonecement, based on polymethyl methacrylate with anextended application phase, used to fill and stabilize vertebral bodies. OSTEOPAL® plus contains zirconium dioxide as an X-ray contrast agent. OSTEOPAL® plus contains the coloring agent chlorophyll VIII (E141) to improve visibility in the surgical field. The bone cement is prepared immediately prior to use by mixing the polymer powder component and the liquid monomer component. A low viscosity paste is applied with the use of application system, placed in the vertebral body, where it cures. OSTEOPAL® plus conforms to ISO 5833 except Annex C

Device Class :

Duns Number: 333623937

Premarket Exempt : No

Product Code : LOD, NDN

Prescription Use : Yes

Device Count : 1