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 00190776434632 Millennium Avalign Technologies, Inc. GAD 2026-10-12 00190776434663 Millennium Avalign Technologies, Inc. GAD 2026-10-12 00190776434700 Millennium Avalign Technologies, Inc. GAD 2026-10-12 04058749044249 NA Fehling Instruments GmbH & Co. KG GAD 2026-10-12 G1415189430 Carnegie Surgical LLC Carnegie Surgical LLC GAD 2026-10-12 00190776434144 Millennium Avalign Technologies, Inc. GAD 2026-10-09 00190776434205 Millennium Avalign Technologies, Inc. GAD 2026-10-09 00190776434212 Millennium Avalign Technologies, Inc. GAD 2026-10-09 00190776434601 Millennium Avalign Technologies, Inc. GAD 2026-10-09 00198506095849 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-10-09 00198506095856 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-10-09 00840277133717 Innomed, Inc. INNOMED, INC. GAD 2026-10-09 00840277133922 Innomed, Inc. INNOMED, INC. GAD 2026-10-09 00840277133939 Innomed, Inc. INNOMED, INC. GAD 2026-10-09 00840277133946 Innomed, Inc. INNOMED, INC. GAD 2026-10-09 00840277133953 Innomed, Inc. INNOMED, INC. GAD 2026-10-09 00840277133960 Innomed, Inc. INNOMED, INC. GAD 2026-10-09 00840277133977 Innomed, Inc. INNOMED, INC. GAD 2026-10-09 00840277133984 Innomed, Inc. INNOMED, INC. GAD 2026-10-09 00840277133991 Innomed, Inc. INNOMED, INC. GAD 2026-10-09 00840277134004 Innomed, Inc. INNOMED, INC. GAD 2026-10-09 00190776433826 Millennium Avalign Technologies, Inc. GAD 2026-10-08 00190776433833 Millennium Avalign Technologies, Inc. GAD 2026-10-08 00190776433871 Millennium Avalign Technologies, Inc. GAD 2026-10-08 00190776434014 Millennium Avalign Technologies, Inc. GAD 2026-10-08 00190776436285 Millennium Avalign Technologies, Inc. GAD 2026-10-08 00190776433628 Millennium Avalign Technologies, Inc. GAD 2026-10-07 00190776433642 Millennium Avalign Technologies, Inc. GAD 2026-10-07 00190776433659 Millennium Avalign Technologies, Inc. GAD 2026-10-07 00190776433741 Millennium Avalign Technologies, Inc. GAD 2026-10-07