Home GUDID B803NL97020120 ORTHOMED
Primary DI B803NL97020120
Brand ORTHOMED
Company ORTHO-MED, INC.
Model OM NL9702-012
Device description WIDE MUSCLE BLADE 50X27MM
Published 2026-06-23
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 FGN Retractor, Non-Self-Retaining
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FGN Retractor, Non-Self-Retaining Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B803NL97020120 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Surgical retractor/retraction system blade, reusable A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. 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 B382SD91471781220 Surgical Direct Surgical Direct, Inc. FGN 2026-07-27 B382SD91471781500 Surgical Direct Surgical Direct, Inc. FGN 2026-07-27 B382SD9141051110 Surgical Direct Surgical Direct, Inc. FGN 2026-07-24 B382SD155310120 Surgical Direct Surgical Direct, Inc. FGN 2026-07-23 B382SD155310140 Surgical Direct Surgical Direct, Inc. FGN 2026-07-23 B382SD1553600 Surgical Direct Surgical Direct, Inc. FGN 2026-07-23 B382SD9070791100 Surgical Direct Surgical Direct, Inc. FGN 2026-07-17 B382SD9073531010 Surgical Direct Surgical Direct, Inc. FGN 2026-07-17 B382SD90738400T0 Surgical Direct Surgical Direct, Inc. FGN 2026-07-17 B382SD9073931130 Surgical Direct Surgical Direct, Inc. FGN 2026-07-17 B382SD974411110 Surgical Direct Surgical Direct, Inc. FGN 2026-07-17 B803NL97020450 ORTHOMED ORTHO-MED, INC. FGN 2026-06-25 B803COD5045680 ORTHOMED ORTHO-MED, INC. FGN 2026-06-23 B803COD5045690 ORTHOMED ORTHO-MED, INC. FGN 2026-06-23 B803COD5045700 ORTHOMED ORTHO-MED, INC. FGN 2026-06-23 B803COD5045710 ORTHOMED ORTHO-MED, INC. FGN 2026-06-23 B803MA1107210 ORTHOMED ORTHO-MED, INC. FGN 2026-06-23 B803MA1107230 ORTHOMED ORTHO-MED, INC. FGN 2026-06-23 B803MA1107370 ORTHOMED ORTHO-MED, INC. FGN 2026-06-23 B803MA1107390 ORTHOMED ORTHO-MED, INC. FGN 2026-06-23 B803MA1108340 ORTHOMED ORTHO-MED, INC. FGN 2026-06-23 B803MA1108360 ORTHOMED ORTHO-MED, INC. FGN 2026-06-23 B803MA1108370 ORTHOMED ORTHO-MED, INC. FGN 2026-06-23 B803NL97020100 ORTHOMED ORTHO-MED, INC. FGN 2026-06-23 B803NL97020110 ORTHOMED ORTHO-MED, INC. FGN 2026-06-23 B803NL97020130 ORTHOMED ORTHO-MED, INC. FGN 2026-06-23 B803NL97020140 ORTHOMED ORTHO-MED, INC. FGN 2026-06-23 B803NL97020150 ORTHOMED ORTHO-MED, INC. FGN 2026-06-23 B803NL97020200 ORTHOMED ORTHO-MED, INC. FGN 2026-06-23 B803NL97020210 ORTHOMED ORTHO-MED, INC. FGN 2026-06-23