Clotalyst and GPS III Platelet Concentration Separation Kit

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

ZIMMER PTE. LTD.

Class:

Class C medical device

Manufactured by:

Biomet Biologics

Therapeutic area:

Orthopaedics

Therapeutic indications:

The GPS III Separator is designed to be used for the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient’s point of care. The PRP can be mixed with autograft or allograft bone prior to application to an orthopedic surgical site as deemed necessary by clinical use requirements. The Clotalyst Kit is designed for the preparation of autologous serum that is to be mixed with the PRP and autograft or allograft for bone graft handling prior to application to an orthopedic surgical site.

Product summary:

Device System Info:[System or Procedure Pack], [Sterile Medical Device], Sterile Medical Device. System.; Models: GPS III SINGLE TUBE ONLY - 800-0744, GPS III MINI TUBE ONLY - 800-0745, GPS III MINI PLATELET CONCENTRATE SEPARATION KIT / WITH 30ML ACD-A - 800-0670A, GPS III - SINGLE UNIT WITH SYRINGES WITH 30ML ACD-A - 800-0675A, GPS™ III - DOUBLE KIT WITH SYRINGES WITH 30ML ACD-A - 800-0680A, ARTHROSCOPIC DELIVERY KIT - 800-0225, SPRAY APPLICATOR KIT - 800-0250, AEROSOL APPLICATOR KIT WITH TIPS 11:1 RATIO - 800-0260, APPLICATOR TIP - 800-0201, APPLICATOR TIP DUAL CANNULA, MALLEABLE 20GA X 10CM (4IN) - 800-0202, APPLICATOR TIP DUAL CANNULA, MALLEABLE 20GA X 18CM (7IN) - 800-0203, BLENDING CONNECTOR WITH SINGLE CANNULA - 800-0204, APPLICATOR SPRAY TIP DUAL CANNULA, MALLEABLE 5MM X 32CM (12.5IN) - 800-0207, RIGID ENDOSCOPIC TIP 5MM DIA X 40 CM (16IN) 1:1 RATIO - 800-0208, RIGID ENDOSCOPIC AEROSOL APPLICATOR TIP 5MM X 40CM (16IN), 1:1 RATIO - 800-0217, GRAFT PREPARATION SYSTEM - 800-0300, CENTRIFUGE 230V 50/60HZ DRUCKER COMPANY - 755VES-230V, INTERNATIONAL DRUCKER UK CORD - 755UKCORD, GPS II MINI SPARE BUCKET KIT 30ML - PURPLE NYLON - 7433, SPARE BUCKET KIT 10ML - RED - 7434, GPS III SPARE BUCKET KIT 60ML GREEN - 7436, BIOMET BIOLOGICS COUNTER BALANCE - 800-0508, BIOMET BIOLOGICS MINI COUNTER BALANCE - 800-0505

Authorization date:

2013-03-28