Home GUDID 10381780274643 Omni-Tract®
Primary DI 10381780274643
Brand Omni-Tract®
Company INTEGRA LIFESCIENCES CORPORATION
Model 3890P
Catalog number 3890P
Device description Instrument Holder Assembly
Published 2018-04-19
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name FFO RETRACTOR, SELF-RETAINING FGN RETRACTOR, NON-SELF-RETAINING GAD RETRACTOR
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FFO Retractor, Self-Retaining Gastroenterology, Urology 1 FGN Retractor, Non-Self-Retaining Gastroenterology, Urology 1 GAD Retractor General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10381780274643 Primary GS1 0 M2483890P1 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780274643 10381780274643
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 Premarket exempt true Serial number true Manufacturing date on label true 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 00190776421977 Millennium Avalign Technologies, Inc. GAD 2026-07-23 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 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