Home GUDID M209195360 ACCU-CUT™ TWO STAGE SYNTHESE
Primary DI M209195360
Brand ACCU-CUT™ TWO STAGE SYNTHESE
Company BIOPRO, INC.
Model 19536
Published 2015-09-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name FZX Guide, Surgical, Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FZX Guide, Surgical, Instrument General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M209195360 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.
Regulatory Flags# DUNS number 618749857 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M209169570 ACCU-CUT™ TWO STAGE 16957 2015-09-16 M209169580 ACCU-CUT™ TWO STAGE S 16958 2015-09-16 M209173000 ACCU-CUT™ 3mm OFFSET 17300 2015-09-16 M209173060 ACCU-CUT™ 3mm OFFSET S 17306 2015-09-16 M209175020 ACCU-CUT™ STANDARD W/2 BLADES 17502 2015-09-16 M209175030 ACCU-CUT™ 1mm OFFSET W/2 BLADES 17503 2015-09-16 M209175040 ACCU-CUT™ 2mm OFFSET W/2 BLADES 17504 2015-09-16 M209175050 ACCU-CUT™ 3mm OFFSET W/2 BLADES 17505 2015-09-16 M209175060 ACCU-CUT™ TWO STAGE W/2 BLADES 17506 2015-09-16 M209177210 ACCU-CUT™ STD MICRO CHOICE 17721 2015-09-16 M209177330 ACCU-CUT™ 1 mm MICRO CHOICE 17733 2015-09-16 M209177340 ACCU-CUT™ 2 mm MICRO CHOICE 17734 2015-09-16 M209177350 ACCU-CUT™ TWO STAGE MICRO 17735 2015-09-16 M209185780 ACCU-CUT™ 2mm W/THREADED K-WIRES 18578 2015-09-16 M209195050 ACCU-CUT™ STANDARD 19505 2015-09-16 M209195060 ACCU-CUT™ 1MM 19506 2015-09-16 M209195070 ACCU-CUT™ 2MM 19507 2015-09-16 M209195080 ACCU-CUT™ 3MM 19508 2015-09-16 M209195090 ACCU-CUT™ TWO STAGE 19509 2015-09-16 M209195100 ACCU-CUT™ LONG ARM 19510 2015-09-16
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