Home GUDID B8038601250 ORTHOMED
Primary DI B8038601250
Brand ORTHOMED
Company ORTHO-MED, INC.
Model OM 86-0125
Device description "C" RETRACTOR 14"
Published 2026-07-22
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 B8038601250 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Hand-held surgical retractor, reusable A hand-held, non-self-retaining 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 dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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 00190776423551 Millennium Avalign Technologies, Inc. GAD 2026-08-07 00190776423742 Millennium Avalign Technologies, Inc. GAD 2026-08-07 00190776423759 Millennium Avalign Technologies, Inc. GAD 2026-08-07 00190776423766 Millennium Avalign Technologies, Inc. GAD 2026-08-07 00190776423773 Millennium Avalign Technologies, Inc. GAD 2026-08-07 00190776423780 Millennium Avalign Technologies, Inc. GAD 2026-08-07 00190776424411 Millennium Avalign Technologies, Inc. GAD 2026-08-07 00190776424428 Millennium Avalign Technologies, Inc. GAD 2026-08-07 00190776424442 Millennium Avalign Technologies, Inc. GAD 2026-08-07 00190776424480 Millennium Avalign Technologies, Inc. GAD 2026-08-07 B382SD484600 Surgical Direct Surgical Direct, Inc. GAD 2026-08-07 G4533315010BC0 PEAK MEDICAL Peak Medical Distribution Inc. GAD 2026-08-07 G4533315012BC0 PEAK MEDICAL Peak Medical Distribution Inc. GAD 2026-08-07 00190776422615 Millennium Avalign Technologies, Inc. GAD 2026-08-03 00190776422691 Millennium Avalign Technologies, Inc. GAD 2026-08-03 00190776422707 Millennium Avalign Technologies, Inc. GAD 2026-08-03 00190776422714 Millennium Avalign Technologies, Inc. GAD 2026-08-03 00190776422776 Millennium Avalign Technologies, Inc. GAD 2026-08-03 00190776422882 Millennium Avalign Technologies, Inc. GAD 2026-08-03 00190776422905 Millennium Avalign Technologies, Inc. GAD 2026-08-03 00190776422264 Millennium Avalign Technologies, Inc. GAD 2026-07-31 00190776422288 Millennium Avalign Technologies, Inc. GAD 2026-07-31 00190776422301 Millennium Avalign Technologies, Inc. GAD 2026-07-31 00190776422530 Millennium Avalign Technologies, Inc. GAD 2026-07-31 00190776422547 Millennium Avalign Technologies, Inc. GAD 2026-07-31 00190776422554 Millennium Avalign Technologies, Inc. GAD 2026-07-31 00190776422561 Millennium Avalign Technologies, Inc. GAD 2026-07-31 00190776422578 Millennium Avalign Technologies, Inc. GAD 2026-07-31 B382S349571000 Surgical Direct Surgical Direct, Inc. GAD 2026-07-31 00199150083107 Medtronic Reusable Instruments MEDTRONIC SOFAMOR DANEK, INC. GAD 2026-07-30