Home GUDID D785SURGICALGUIDE0 SURGICAL GUIDE
Primary DI D785SURGICALGUIDE0
Brand SURGICAL GUIDE
Company OCO BIOMEDICAL INC
Model 3D PRINTED SURGICAL GUIDE
Catalog number SURGICAL GUIDE
Device description 3D PRINTED SURGICAL GUIDE
Published 2024-12-03
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name NDP Accessories, Implant, Dental, Endosseous
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NDP Accessories, Implant, Dental, Endosseous Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D785SURGICALGUIDE0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Custom-made orthopaedic/craniofacial surgical guide A custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is typically manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 094146123 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D785OTCAP100 10 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERT OT CAP 10 OT CAP 10 2026-02-04 D785OTCAP40 4 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERT OT CAP 4 OT CAP 4 2026-02-04 D785OTPINK40 4 PACK OT EQUATOR PINK INSERTS OT PINK 4 OT PINK 4 2026-02-04 D785OTPU20 2 PACK OT EQUATOR IMPRESSION COPING OT PU 2 OT PU 2 2026-02-04 D785OTYELLOW40 4 PACK OT EQUATOR YELLOW INSERT OT YELLOW 4 OT YELLOW 4 2026-02-04 D78589490 TSI/ERI Locator Abutment Locator Abutment 0mm 8949 2025-09-03 D785325SB0 SCAN BODY TSI/ERI 3.25MM SCAN BODY 3.25 SB 2024-06-26 D78540SB0 SCAN BODY TSI/ERI 4.0MM SCAN BODY 4.0 SB 2024-06-26 D78550SB0 SCAN BODY TSI/ERI 5.0MM SCAN BODY 5.0 SB 2024-06-26 D78532530SA0 SCAN ADAPTER 3.25MM ENGAGE PEEK SCAN ADAPTER 32530 SA 2024-03-12 D78532530SB0 SCAN BODY 3.25MM ENGAGE SCAN BODY 32530 SB 2024-03-12 D7854035SA0 SCAN ADAPTER 4.0MM ENGAGE PEEK SCAN ADAPTER 4035 SA 2024-03-12 D7854035SB0 SCAN BODY 4.0MM ENGAGE SCAN BODY 4035 SB 2024-03-12 D7855045SA0 SCAN ADAPTER 5.0MM ENGAGE PEEK SCAN ADAPTER 5045 SA 2024-03-12 D7855045SB0 SCAN BODY 5.0MM ENGAGE SCAN BODY 5045 SB 2024-03-12 D7856057SA0 SCAN ADAPTER 6.0MM ENGAGE PEEK SCAN ADAPTER 6057 SA 2024-03-12 D7856057SB0 SCAN BODY 6.0MM ENGAGE SCAN BODY 6057 SB 2024-03-12 D7850330T0 Osteotomy Former 3.3mm Osteotomy Former 0330TN 2024-12-03 D7853610ENGAGE0 Two Stage Bone Level Dental Implant Engage 3610 ENGAGE 2024-12-03 D7853610ENGPLS0 Two Stage Bone Level Implant Engage Plus 3610 Engage Plus 2024-12-03
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