Equipment Drapes - India CDSCO Medical Device Registration
Equipment Drapes is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000438_bb5f7aa4a40cd61e42fd9a406061367d_bbc52f3cb72e97d34fb560a640277690. This device is marketed under the brand name ROSA Robotic Unit Drape. The license holder is Zimmer India Private Limited, and it is classified as Device Class Class A. The approving authority is CDSCO.
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Brand Name
ROSA Robotic Unit Drape
License Holder
Zimmer India Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/. It functions as a physical barrier to prevent cross-contamination between the instrument/equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. It is typically made of flexible plastic and shaped to fit the type of instrument/equipment. This is a single-use device [not to be reprocessed].
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