TECRES SPA

Address:VIA ANDREA DORIA 6,VERONA Veneto,IT

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Kit, Surgical Instrument, Disposable (KDD) (5) Bone Cement (LOD) (3) Bone Cement, Antibiotic (MBB) (2) Cement, Bone, Vertebroplasty (NDN) (1) Dispenser, Cement (KIH) (1) Orthopedic Manual Surgical Instrument (LXH) (1)

Premarket Exempt

No Yes

Clear

MectaCem-X LV with Gentamicin - 08031497002149 Catalog Number :

Device Description : MectaCem-X LV with Gentamicin is a low viscosity antibiotic-loaded polymethylmet MectaCem-X LV with Gentamicin is a low viscosity antibiotic-loaded polymethylmethacrylate bone cements. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X LV with Gentamicin is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Device Class : 2

Duns Number: 435428396

Premarket Exempt : No

Product Code : LOD, MBB

Prescription Use : Yes

Device Count : 1

MectaCem-X HV with Gentamicin - 08031497002163 Catalog Number :

Device Description : MectaCem-X HV with Gentamicin is a low viscosity antibiotic-loaded polymethylme MectaCem-X HV with Gentamicin is a low viscosity antibiotic-loaded polymethylmethacrylate bone cements. It is composed by two components (40g powder and 14,7g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X HV with Gentamicin is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Device Class : 2

Duns Number: 435428396

Premarket Exempt : No

Product Code : LOD, MBB

Prescription Use : Yes

Device Count : 1

GUN-01 - 08031497002187 Catalog Number :

Device Description : GUN-01 is intended to be used for helping the extrusion (and hence the delivery) GUN-01 is intended to be used for helping the extrusion (and hence the delivery) of bone cement only from the Tecres’ syringes Cemex System Device.

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : KIH

Prescription Use : No

Device Count : 1

Shoulder Cannula - 08031497002194 Catalog Number :

Device Description : Shoulder Cannula is intended to be used to deliver bone cement in the humerus th Shoulder Cannula is intended to be used to deliver bone cement in the humerus through Tecres' Cemex System.

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : KDD

Prescription Use : No

Device Count : 1

Cannula for Knee - 08031497002217 Catalog Number :

Device Description : Cannula for Knee is intended to be used to deliver bone cement in the knee throu Cannula for Knee is intended to be used to deliver bone cement in the knee through Tecres' Cemex System.

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : KDD

Prescription Use : No

Device Count : 1

Revision Cannula - 08031497002224 Catalog Number :

Device Description : Revision Cannula is intended to be used to distal femoral bone cement delivery t Revision Cannula is intended to be used to distal femoral bone cement delivery through Tecres' Cemex System.

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : KDD

Prescription Use : No

Device Count : 1

Hip Cannula - 08031497002231 Catalog Number :

Device Description : Hip Cannula is intended to be used to deliver bone cement through Tecres' Cemex System.

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : KDD

Prescription Use : No

Device Count : 1

CEMENT PRESSURIZER - 08031497002248 Catalog Number :

Device Description : Cement Pressurizer is intended to be used in cemented arthroplasty for the press Cement Pressurizer is intended to be used in cemented arthroplasty for the pressurization of the cement inside the femoral canal during retrograde filling.

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

HP Connection Tube - 08031497002255 Catalog Number :

Device Description : HP Connection Tube is intended for the connection of delivery devices to injecti HP Connection Tube is intended for the connection of delivery devices to injection devices through Luer-Lock connections for the extrusion of bone void fillers or acrylic resins.

Device Class : 1

Duns Number: 435428396

Premarket Exempt : Yes

Product Code : KDD

Prescription Use : No

Device Count : 1

CEMENT KIT - 08031497002316 Catalog Number :

Device Description : Mendec Spine HV is a highly viscous, radio-opaque acrylic resin (PMMA based) for Mendec Spine HV is a highly viscous, radio-opaque acrylic resin (PMMA based) for vertebral augmentation procedures available as a closed mixing unit (the powder and liquid components are enclosed in a syringe-like device).

Device Class : 2

Duns Number: 435428396

Premarket Exempt : No

Product Code : LOD, NDN

Prescription Use : Yes

Device Count : 1

Previous 1 2 3 4 5 … 9 Next