Home GUDID B803NL9701H0 ORTHOMED
Primary DI B803NL9701H0
Brand ORTHOMED
Company ORTHO-MED, INC.
Model OM NL9701-H
Device description MCCULLOCH RETRACTOR BODY HINGED ARMS
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 B803NL9701H0 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 00198506091926 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-07-22 00198506092015 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-07-22 00198506093685 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-07-22 00841731153104 ARTEMIS FUZE VILEX LLC GAD 2026-07-22 00841731153111 ARTEMIS FUZE VILEX LLC GAD 2026-07-22 B8038600980 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8038600990 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B803860120L0 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8038601250 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039018420 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039018430 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039018840 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039030020 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B803903220010 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B803903220020 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039401000 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039601360 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039601370 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039601390 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B8039601400 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 B803NL97010 ORTHOMED ORTHO-MED, INC. GAD 2026-07-22 00190776402174 Millennium Avalign Technologies, Inc. GAD 2026-07-21 00190776403317 Millennium Avalign Technologies, Inc. GAD 2026-07-21 00190776403324 Millennium Avalign Technologies, Inc. GAD 2026-07-21 00190776403362 Millennium Avalign Technologies, Inc. GAD 2026-07-21 00840183532185 BR Surgical, LLC BR Surgical, LLC GAD 2026-07-21 00840183532192 BR Surgical, LLC BR Surgical, LLC GAD 2026-07-21 00840183532222 BR Surgical, LLC BR Surgical, LLC GAD 2026-07-21 00840183532239 BR Surgical, LLC BR Surgical, LLC GAD 2026-07-21 00840183532628 BR Surgical, LLC BR Surgical, LLC GAD 2026-07-21