Home GUDID 00860009815780 EmbedMed
Primary DI 00860009815780
Brand EmbedMed
Company 3D LIFEPRINTS UK LTD
Model OTHSG-S
Device description Sterile Patient-specific, Orthopedic Surgical Guide
Published 2026-03-30
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name LLZ System, Image Processing, Radiological PBF Orthopaedic Surgical Planning And Instrument Guides
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LLZ System, Image Processing, Radiological Radiology 2 PBF Orthopaedic Surgical Planning And Instrument Guides Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860009815780 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 00860009815780 00860009815780 860009815780 0860009815780
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 220777297 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label false 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# 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 00810007633282 AccuStride System Medcad PBF 2025-06-30 00810007633299 AccuStride System Medcad PBF 2025-06-30 00810007633305 AccuStride System Medcad PBF 2025-06-30 00810007633312 AccuStride System Medcad PBF 2025-06-30 00810007633244 AccuStride System Medcad PBF 2025-06-10 00810111224680 TMC PSI Cut Guide System Treace Medical Concepts, Inc. PBF 2025-05-22 00810111224697 TMC PSI Cut Guide System Treace Medical Concepts, Inc. PBF 2025-05-22 00081000763324 AccuStride System Medcad PBF 2025-05-05 00810007633251 AccuStride System Medcad PBF 2025-05-05 00810007633268 AccuStride System Medcad PBF 2025-05-05 00198715251623 BrainSpec Core™ Software BrainSpec Inc. LLZ 2025-02-10 00670082000610 Modus Plan Synaptive Medical Inc LLZ 2025-01-17 00810111223553 TMC PSI Cut Guide System Treace Medical Concepts, Inc. PBF 2024-11-15 00810111223560 TMC PSI Cut Guide System Treace Medical Concepts, Inc. PBF 2024-11-15 00810111223577 TMC PSI Cut Guide System Treace Medical Concepts, Inc. PBF 2024-11-15 00810111223584 TMC PSI Cut Guide System Treace Medical Concepts, Inc. PBF 2024-11-15 00810111223447 TMC PSI Cut Guide System Treace Medical Concepts, Inc. PBF 2024-11-14 00810111223454 TMC PSI Cut Guide System Treace Medical Concepts, Inc. PBF 2024-11-14 00810111223478 TMC PSI Cut Guide System Treace Medical Concepts, Inc. PBF 2024-11-14 00810111223621 TMC PSI Cut Guide System Treace Medical Concepts, Inc. PBF 2024-11-14 00195278753472 ViewPoint GE Healthcare GmbH LLZ 2024-07-15 00810111222723 TMC PSI Cut Guide System Treace Medical Concepts, Inc. PBF 2024-03-11 00810111222730 TMC PSI Cut Guide System Treace Medical Concepts, Inc. PBF 2024-03-11 00810111222259 TMC PSI Cut Guide System Treace Medical Concepts, Inc. PBF 2023-11-17 00810111222266 TMC PSI Cut Guide System Treace Medical Concepts, Inc. PBF 2023-11-17 00810111222273 TMC PSI Cut Guide System Treace Medical Concepts, Inc. PBF 2023-11-17 00810111222280 TMC PSI Cut Guide System Treace Medical Concepts, Inc. PBF 2023-11-17