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Single use Arthroscopy & Orthopedic Instruments - India CDSCO Medical Device Registration

Single use Arthroscopy & Orthopedic Instruments is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000525_01dae13d82630b81d82a3b1260a47a6f_1718799ea4259937631fd3aebac5d086. This device is marketed under the brand name BIOTEK, Arthrovims, BOTS. The license holder is Chetan Meditech Pvt Ltd, and it is classified as Device Class Class B. The approving authority is Gujarat.

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CDSCO Registered
Class Class B
Single use Arthroscopy & Orthopedic Instruments
UID: MFG/MD/2022/000525_01dae13d82630b81d82a3b1260a47a6f_1718799ea4259937631fd3aebac5d086

Brand Name

BIOTEK, Arthrovims, BOTS

Device Class

Class B

Approving Authority

Gujarat

Product Information

These devices are surgically Invasive instruments that are intended for medical purposes to manipulate tissue/bone/suture, or for use with other devices in arthroscopic & open surgery. Specific intended use of these devices are as follows: Suture Passing Instruments: They are intended to aid in passing suture through soft tissue during the arthroscopic and open procedures. Guidewire: These devices are used to aid in the placement of cannulated implants and instruments and to hold the soft tissue in position according to surgical requirements. Drill Bit: Drill Bits are available in various lengths and diameters as related to ligament anchors and other devices. They are used to create sockets and tunnels in bone. Reamers: Reamers are designed to be used to create sockets and tunnels in bone. Chondral Resurfacing System/ kit: Osteochondral Resurfacing system are intended for osteochondral transfer.

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