Infusion Sleeve - India CDSCO Medical Device Registration

Infusion Sleeve is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000222_6b479b2d174ca6165be3e01032c55c9a_909cd8ba3a297c4ebb1ae11029aa8ad7. This device is marketed under the brand name 23 Gauge Vitrectomy Cutter. The license holder is Johnson & Johnson Surgical Vision India Pvt Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Infusion Sleeve

UID: IMP/MD/2023/000222_6b479b2d174ca6165be3e01032c55c9a_909cd8ba3a297c4ebb1ae11029aa8ad7

Brand Name

23 Gauge Vitrectomy Cutter

License Holder

Johnson & Johnson Surgical Vision India Pvt Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

The AMO Irrigation Sleeve and Test Chamber are utilized in conjunction with the SERIES III Phaco Handpiece during the phacoemulsification procedure to break up (23 Gauge Vitrectomy Cutter) the nucleus of the cataractous lens and remove the remaining nuclear fragments. The handpiece has been designed for use with the DIPLOMAX, OPSYS and DIPLOMATE families of phacoemulsification machines. The Infusion Sleeve and Test Chamber are designed as reusable products for reuse up to 20 times and have been sterilized by gamma radiation

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Tubing Pack(SOVEREIGN Compact Tubing/DIPLOMAX II Set )

Brand: 23 Gauge Vitrectomy Cutter

Johnson & Johnson Surgical Vision India Pvt Ltd

Infusion Sleeve - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Tubing Pack(SOVEREIGN Compact Tubing/DIPLOMAX II Set )

Multi Use Pack

System Accessories

System Accessories

System Accessories

System Accessories

Phaco Handpiece

Single-Use Pack

Vitrectomy Cutter

FUSION™ Pack

Refractive Extended Depth of Focus Intraocular Lens with Simplicity Preloaded Delivery System

Patient Interface(ELITA Patient Interface )

Patient Interface

Phaco Disposable Tips

Phaco Disposable Tips

Phaco Disposable Tips

Phaco Disposable Tips

Phaco Disposable Tips

Phaco Disposable Tips

Phaco Reusable Tips