Home GUDID 00860012759408 TECHFIT
Primary DI 00860012759408
Brand TECHFIT
Company Techfit Digital Surgery, Inc.
Model 0
Catalog number FFCOD
Device description Final Orthog Surgical Splint Digital
Published 2024-09-13
Public version status Update
Distribution status Not 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 DZJ Driver, Wire, And Bone Drill, Manual LLZ System, Image Processing, Radiological
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DZJ Driver, Wire, And Bone Drill, Manual Dental 2 LLZ System, Image Processing, Radiological Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860012759408 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860012759408 00860012759408 860012759408 0860012759408
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 117050279 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00754016387128 ANDI Imeka Solutions Inc LLZ 2026-05-14 00198953059173 ViewPoint GE Healthcare GmbH LLZ 2026-02-27 00198715251623 BrainSpec Core™ Software BrainSpec Inc. LLZ 2025-02-10 00670082000610 Modus Plan Synaptive Medical Inc LLZ 2025-01-17 00195278753472 ViewPoint GE Healthcare GmbH LLZ 2024-07-15 00350227000520 Eaglesoft PATTERSON TECHNOLOGY CENTER LLZ 2023-10-25 00754016387111 ANDI Imeka Solutions Inc LLZ 2023-09-01 00195278517340 ViewPoint GE Healthcare GmbH LLZ 2023-02-15 00670082000511 Modus Plan Synaptive Medical Inc LLZ 2022-12-13 00817886020400 Joints MEDSTRAT, INC. LLZ 2021-12-16 00817886020394 Joints MEDSTRAT, INC. LLZ 2021-10-15 00817886020387 Joints MEDSTRAT, INC. LLZ 2021-09-08 00817886020370 Joints MEDSTRAT, INC. LLZ 2021-07-30 00817886020363 Joints MEDSTRAT, INC. LLZ 2021-07-02 00817886020356 Joints MEDSTRAT, INC. LLZ 2021-06-01 00817886020349 Joints MEDSTRAT, INC. LLZ 2021-04-05 00817886020332 Joints MEDSTRAT, INC. LLZ 2021-02-26 00817886020325 Joints MEDSTRAT, INC. LLZ 2021-01-29 00817886020318 Joints MEDSTRAT, INC. LLZ 2020-12-11 00817886020301 Joints MEDSTRAT, INC. LLZ 2020-11-02 00817886020295 Joints MEDSTRAT, INC. LLZ 2020-10-05 00350227300071 FUSE PATTERSON TECHNOLOGY CENTER LLZ 2020-09-19 00817886020288 Joints MEDSTRAT, INC. LLZ 2020-08-31 00817886020226 Joints MEDSTRAT, INC. LLZ 2020-08-03 00817886020233 Joints MEDSTRAT, INC. LLZ 2020-08-03 00817886020240 Joints MEDSTRAT, INC. LLZ 2020-08-03 00817886020257 Joints MEDSTRAT, INC. LLZ 2020-08-03 00817886020264 Joints MEDSTRAT, INC. LLZ 2020-08-03 00817886020271 Joints MEDSTRAT, INC. LLZ 2020-08-03 00350227300064 FUSE PATTERSON TECHNOLOGY CENTER LLZ 2020-06-02