Home GUDID 00860012759439 TECHFIT
Primary DI 00860012759439
Brand TECHFIT
Company Techfit Digital Surgery, Inc.
Model 0
Catalog number DISRP
Device description Digitally Integrated Surgical Reconstruction Platform - DISRP
Published 2025-03-10
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 LLZ System, Image Processing, Radiological
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LLZ System, Image Processing, Radiological Radiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860012759439 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 00860012759439 00860012759439 860012759439 0860012759439
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 117050279 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07350092810722 Sectra Orthopedic Package Sectra AB LLZ 2026-09-06 00754016387128 ANDI Imeka Solutions Inc LLZ 2026-05-14 00198953059173 ViewPoint GE Healthcare GmbH LLZ 2026-02-27 00817886020677 Joints MEDSTRAT, INC. LLZ 2026-02-16 00817886020660 Joints MEDSTRAT, INC. LLZ 2025-08-09 00817886020653 Joints MEDSTRAT, INC. LLZ 2025-06-27 00817886020646 Joints MEDSTRAT, INC. LLZ 2025-04-30 00817886020639 Joints MEDSTRAT, INC. LLZ 2025-03-07 00198715251623 BrainSpec Core™ Software BrainSpec Inc. LLZ 2025-02-10 00817886020622 Joints MEDSTRAT, INC. LLZ 2025-02-03 00670082000610 Modus Plan Synaptive Medical Inc LLZ 2025-01-17 00817886020615 Joints MEDSTRAT, INC. LLZ 2024-12-09 00817886020608 Joints MEDSTRAT, INC. LLZ 2024-11-01 00817886020592 Joints MEDSTRAT, INC. LLZ 2024-08-31 00195278753472 ViewPoint GE Healthcare GmbH LLZ 2024-07-15 00817886020585 Joints MEDSTRAT, INC. LLZ 2024-06-08 00817886020578 Joints MEDSTRAT, INC. LLZ 2024-04-12 00817886020561 Joints MEDSTRAT, INC. LLZ 2024-02-10 00817886020554 Joints MEDSTRAT, INC. LLZ 2023-11-13 00350227000520 Eaglesoft PATTERSON TECHNOLOGY CENTER LLZ 2023-10-25 00754016387111 ANDI Imeka Solutions Inc LLZ 2023-09-01 00817886020516 Joints MEDSTRAT, INC. LLZ 2023-05-29 00817886020509 Joints MEDSTRAT, INC. LLZ 2023-04-03 00817886020493 Joints MEDSTRAT, INC. LLZ 2023-03-06 00195278517340 ViewPoint GE Healthcare GmbH LLZ 2023-02-15 00817886020486 Joints MEDSTRAT, INC. LLZ 2023-01-20 00670082000511 Modus Plan Synaptive Medical Inc LLZ 2022-12-13 00817886020479 Joints MEDSTRAT, INC. LLZ 2022-10-29 00817886020462 Joints MEDSTRAT, INC. LLZ 2022-09-05 00817886020455 Joints MEDSTRAT, INC. LLZ 2022-08-01