Home GUDID 00860009784925 Flap Marking Template
Primary DI 00860009784925
Brand Flap Marking Template
Company Mirrorme3d, LLC
Model MFFT
Device description Patient specific, 3D printed, single use surgical flap marking template based a patient’s baseline status and treatment plan. RX only, non-diagnostic.
Published 2023-03-17
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 HWT Template
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWT Template Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860009784925 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 00860009784925 00860009784925 860009784925 0860009784925
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 060396278 Device count 1 DM exempt true Premarket exempt true 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 true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10603295553588 ATTUNE DEPUY ORTHOPAEDICS, INC. HWT 2026-08-26 10603295553595 ATTUNE DEPUY ORTHOPAEDICS, INC. HWT 2026-08-26 10603295553601 ATTUNE DEPUY ORTHOPAEDICS, INC. HWT 2026-08-26 10603295553618 ATTUNE DEPUY ORTHOPAEDICS, INC. HWT 2026-08-26 10705034579900 N/A Medos International Sàrl HWT 2026-08-26 10705034579917 N/A Medos International Sàrl HWT 2026-08-26 10705034579924 N/A Medos International Sàrl HWT 2026-08-26 00889024711464 Comp Mini Humeral Tray Trial Stem Adapter Zimmer, Inc. HWT 2026-08-25 00889024713277 Universal Uni Knee Tensor Zimmer, Inc. HWT 2026-08-25 00889024713284 Right Uni Knee Tensor Zimmer, Inc. HWT 2026-08-25 00889024713291 Left Uni Knee Tensor Zimmer, Inc. HWT 2026-08-25 00860009784918 Template Mirrorme3d, LLC HWT 2023-02-16 10885862015815 NA Exactech, Inc. HWT 2022-10-04 10885862015822 NA Exactech, Inc. HWT 2022-10-04 10885862015839 NA Exactech, Inc. HWT 2022-10-04 10885862015846 NA Exactech, Inc. HWT 2022-10-04 10885862015853 NA Exactech, Inc. HWT 2022-10-04 10885862015860 NA Exactech, Inc. HWT 2022-10-04 10885862015877 NA Exactech, Inc. HWT 2022-10-04 10885862015884 NA Exactech, Inc. HWT 2022-10-04 10885862015891 NA Exactech, Inc. HWT 2022-10-04 10885862015907 NA Exactech, Inc. HWT 2022-10-04 10885862015914 NA Exactech, Inc. HWT 2022-10-04 10885862015921 NA Exactech, Inc. HWT 2022-10-04 10885862015938 NA Exactech, Inc. HWT 2022-10-04 10885862015945 NA Exactech, Inc. HWT 2022-10-04 10885862015952 NA Exactech, Inc. HWT 2022-10-04 10885862015969 NA Exactech, Inc. HWT 2022-10-04 10885862015976 NA Exactech, Inc. HWT 2022-10-04 10885862015983 NA Exactech, Inc. HWT 2022-10-04