Bone Cement
- UID
- IMP/MD/2019/000365_7be8b272b193aa37b1fef070934f01a6_c017a79a60cc53f496494543020cfa58
- Device class
- Class C
- Brand name
- Without Antibiotic
- Approving authority
- CDSCO
- Product information
- Optipac is a mixing and application system pre- packed with Refobacin Revision. Refobacin Revision is used for stable anchoring of suitable joint prostheses in primary operations, with added protection against infection. Also in revision operations resulting from aseptic loosening of the prosthesis and infection of the prosthesis by gentamicin- and/or clindamycin-sensitive strains. Refobacin Revision is indicated for use in the fabrication and fixation of short-term total or hemi joint spacers in patients who require a two-stage revision. The device is intended for use in conjunction with systemic antimicrobial therapy (Without Antibiotic). Spacers are utilized to maintain the joint´s soft tissue envelope. The spacers may allow limited weight bearing or other physical activities during implantation depending on the spacer´s design and patient´s ability to comply with partial weight bearing instructions
Bone Cement is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000365_7be8b272b193aa37b1fef070934f01a6_c017a79a60cc53f496494543020cfa58. This device is marketed under the brand name Without Antibiotic. The license holder is Zimmer India Private Limited ,No. 17, Ground Floor and Mezzanine Floor, Thiruneermalai Road, Nagalkeni, Chrompet ,Chennai Tamil Nadu ,600044 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.
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