SURGICAL KIT GUIDED SURGERY KIT

GUDID D785GUIDEDSURGERYKIT0

GUIDED SURGERY SURGICAL INSTRUMENTATION KIT

OCO BIOMEDICAL INC

Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable Dental/maxillofacial surgical procedure kit, non-medicated, reusable

• Primary Device ID: D785GUIDEDSURGERYKIT0
• NIH Device Record Key: ac15a045-21da-411d-8c07-01961a0c9422
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGICAL KIT
• Version Model Number: GUIDED SURGERY SURGICAL INSTRUMENTATION KIT
• Catalog Number: GUIDED SURGERY KIT
• Company DUNS: 094146123
• Company Name: OCO BIOMEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D785GUIDEDSURGERYKIT0 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[D785GUIDEDSURGERYKIT0]

Moist Heat or Steam Sterilization

[D785GUIDEDSURGERYKIT0]

Moist Heat or Steam Sterilization

[D785GUIDEDSURGERYKIT0]

Moist Heat or Steam Sterilization

[D785GUIDEDSURGERYKIT0]

Moist Heat or Steam Sterilization

[D785GUIDEDSURGERYKIT0]

Moist Heat or Steam Sterilization

[D785GUIDEDSURGERYKIT0]

Moist Heat or Steam Sterilization

[D785GUIDEDSURGERYKIT0]

Moist Heat or Steam Sterilization

[D785GUIDEDSURGERYKIT0]

Moist Heat or Steam Sterilization

[D785GUIDEDSURGERYKIT0]

Moist Heat or Steam Sterilization

[D785GUIDEDSURGERYKIT0]

Moist Heat or Steam Sterilization

[D785GUIDEDSURGERYKIT0]

Moist Heat or Steam Sterilization

[D785GUIDEDSURGERYKIT0]

Moist Heat or Steam Sterilization

[D785GUIDEDSURGERYKIT0]

Moist Heat or Steam Sterilization

[D785GUIDEDSURGERYKIT0]

Moist Heat or Steam Sterilization

[D785GUIDEDSURGERYKIT0]

Moist Heat or Steam Sterilization

[D785GUIDEDSURGERYKIT0]

Moist Heat or Steam Sterilization

[D785GUIDEDSURGERYKIT0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-20
• Device Publish Date: 2024-03-12

On-Brand Devices [SURGICAL KIT]

• D785GUIDEDSURGERYKIT0: GUIDED SURGERY SURGICAL INSTRUMENTATION KIT
• D785ENGAGECOMPACTKIT0: ENGAGE SURGICAL INSTRUMENTATION COMPACT KIT