Sterile High-pressure Angiographic Syringes(OptiVantage®/OptiOne® CT Syringe with Coiled Tube and Filling Spike ? 200mL) - India CDSCO Medical Device Registration

Sterile High-pressure Angiographic Syringes(OptiVantage®/OptiOne® CT Syringe with Coiled Tube and Filling Spike ? 200mL) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000427_7e691be18bcb9909484a6933ad3877f7_ed1b19c4ec6729657e6bafb2af5fd1b6. This device is marketed under the brand name 1500mm. The license holder is M/s. Guerbet India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Sterile High-pressure Angiographic Syringes(OptiVantage®/OptiOne® CT Syringe with Coiled Tube and Filling Spike ? 200mL)

UID: IMP/MD/2022/000427_7e691be18bcb9909484a6933ad3877f7_ed1b19c4ec6729657e6bafb2af5fd1b6

Brand Name

1500mm

License Holder

M/s. Guerbet India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

Sterile High-pressure Angiographic Syringes for Single-Use are intended for injection of contrast media or saline; They shall be used with a legally marketed angiographic injector. Contraindication: These devices are not intended for multiple-use, drug infusion, chemotherapy, the use in patients < 10kg or any other use for which the device is not indicated.