Home GUDID M24811301R1 Omni-Tract®
Primary DI M24811301R1
Brand Omni-Tract®
Company INTEGRA LIFESCIENCES CORPORATION
Model 11301R
Catalog number 11301R
Device description Omni-Tract® Aluminum Malleable Radiolucent Blade, 2in x 6-1/2in (5.1cm x 16.5cm)
Published 2018-02-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 10381780271628 Primary GS1 0 M24811301R1 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780271628 10381780271628
GMDN Terms# Term, Definition table Term Definition Surgical retraction system, reusable A frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 963856096 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 true 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 00190776395483 Millennium Avalign Technologies, Inc. GAD 2026-07-14 B382SD123750 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD123760 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD123780 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD124326191140 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD209910FSANT0 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD209920FSANT0 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD209923FSANT0 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD907126105T0 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD907247080T0 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD907247112T0 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD90724711T0 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD907249100 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD907284670 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 B382SD907337510 Surgical Direct Surgical Direct, Inc. GAD 2026-07-14 G453152901750 PEAK MEDICAL Peak Medical Distribution Inc. GAD 2026-07-14 00198506091872 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-07-10 00810158211193 PRINCETON Princeton Medical Group, Inc. GAD 2026-07-10 00810158219861 PRINCETON Princeton Medical Group, Inc. GAD 2026-07-10 00888937033687 ONETRAC Coopersurgical, Inc. GAD 2026-07-10 00888937033694 ONETRAC Coopersurgical, Inc. GAD 2026-07-10 00888937033700 ONETRAC Coopersurgical, Inc. GAD 2026-07-10 00888937033717 ONETRAC Coopersurgical, Inc. GAD 2026-07-10 00888937033724 ONETRAC Coopersurgical, Inc. GAD 2026-07-10 00888937033731 ONETRAC LX Coopersurgical, Inc. GAD 2026-07-10 00888937033748 ONETRAC LX Coopersurgical, Inc. GAD 2026-07-10 00888937033755 ONETRAC LX Coopersurgical, Inc. GAD 2026-07-10 00888937033762 ONETRAC LX Coopersurgical, Inc. GAD 2026-07-10 00888937033779 ONETRAC LX Coopersurgical, Inc. GAD 2026-07-10 00888937033786 ONETRAC™ LXS Coopersurgical, Inc. GAD 2026-07-10
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