Home GUDID B8039018420 ORTHOMED
Primary DI B8039018420
Brand ORTHOMED
Company ORTHO-MED, INC.
Model OM 90-1842
Device description CALIBRATED ORTHO SPREADER W/O TEETH SM FLAT 6 1/2" SMOOTH
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 B8039018420 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 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