Home GUDID M248114421 Omni-Tract®
Primary DI M248114421
Brand Omni-Tract®
Company INTEGRA LIFESCIENCES CORPORATION
Model 11442
Catalog number 11442
Device description Omni-Tract® Kelly Swivel Retractor, Square Shaft, 2in x 3in (5.1cm x 7.6cm)
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 10381780271925 Primary GS1 0 M248114421 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780271925 10381780271925
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 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 B803NL9701H0 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
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