Home GUDID B8039018650 ORTHOMED
Primary DI B8039018650
Brand ORTHOMED
Company ORTHO-MED, INC.
Model OM 90-1865
Catalog number OM 90-1865
Device description CALIBRATED FEMORAL TIBIAL SPREADER W/ROUND DISKS 7"
Published 2026-10-27
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name GAD Retractor
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GAD Retractor General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B8039018650 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Self-retaining surgical retractor, reusable A hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 086618626 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 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 00190776439811 Millenium Avalign Technologies, Inc. GAD 2026-10-28 B382SD907310080 Surgical Direct Surgical Direct, Inc. GAD 2026-10-28 B382SD9141781200 Surgical Direct Surgical Direct, Inc. GAD 2026-10-28 B382SD91417912190 Surgical Direct Surgical Direct, Inc. GAD 2026-10-28 00190776437145 Millennium Avalign Technologies, Inc. GAD 2026-10-26 00190776437152 Millennium Avalign Technologies, Inc. GAD 2026-10-26 00190776437169 Millennium Avalign Technologies, Inc. GAD 2026-10-26 00190776439781 Millenium Avalign Technologies, Inc. GAD 2026-10-26 00190776436957 Millennium Avalign Technologies, Inc. GAD 2026-10-23 00190776437015 Millennium Avalign Technologies, Inc. GAD 2026-10-23 00190776437022 Millennium Avalign Technologies, Inc. GAD 2026-10-23 00840277134011 Innomed, Inc. INNOMED, INC. GAD 2026-10-22 00190776435615 Millennium Avalign Technologies, Inc. GAD 2026-10-21 00190776435622 Millennium Avalign Technologies, Inc. GAD 2026-10-21 00190776435660 Millennium Avalign Technologies, Inc. GAD 2026-10-21 00190776435707 Millennium Avalign Technologies, Inc. GAD 2026-10-21 00190776435714 Millennium Avalign Technologies, Inc. GAD 2026-10-21 00724995323998 V. Mueller STERIS Deutschland GmbH GAD 2026-10-21 00840338612656 Made-To-Order TORNIER, INC. GAD 2026-10-21 00190776435578 Millennium Avalign Technologies, Inc. GAD 2026-10-20 00190776435585 Millennium Avalign Technologies, Inc. GAD 2026-10-20 00190776437787 Millennium Avalign Technologies, Inc. GAD 2026-10-20 00190776439699 Millenium Avalign Technologies, Inc. GAD 2026-10-20 B382SD907310070 Surgical Direct Surgical Direct, Inc. GAD 2026-10-20 00190776435219 Millennium Avalign Technologies, Inc. GAD 2026-10-19 00190776435233 Millennium Avalign Technologies, Inc. GAD 2026-10-19 00190776435264 Millennium Avalign Technologies, Inc. GAD 2026-10-19 00190776435301 Millennium Avalign Technologies, Inc. GAD 2026-10-19 03661219011590 LANDANGER LANDANGER GAD 2026-10-19 G4533310960 PEAK MEDICAL Peak Medical Distribution Inc. GAD 2026-10-19