Home GUDID M248110501 Omni-Tract®
Primary DI M248110501
Brand Omni-Tract®
Company INTEGRA LIFESCIENCES CORPORATION
Model 11050
Catalog number 11050
Device description Omni-Tract® Omni-Flex® Support Arm
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 FFO RETRACTOR, SELF-RETAINING
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FFO Retractor, Self-Retaining Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10381780271550 Primary GS1 0 M248110501 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10381780271550 10381780271550
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 B382SD918174150 Surgical Direct Surgical Direct, Inc. FFO 2026-07-13 B382SD9183701030 Surgical Direct Surgical Direct, Inc. FFO 2026-07-13 B382SD484610 Surgical Direct Surgical Direct, Inc. FFO 2026-07-09 B382SD484630 Surgical Direct Surgical Direct, Inc. FFO 2026-07-09 B382SD484640 Surgical Direct Surgical Direct, Inc. FFO 2026-07-09 B382SD484650 Surgical Direct Surgical Direct, Inc. FFO 2026-07-09 B382SD484660 Surgical Direct Surgical Direct, Inc. FFO 2026-07-09 B382SD484670 Surgical Direct Surgical Direct, Inc. FFO 2026-07-09 B382SD484680 Surgical Direct Surgical Direct, Inc. FFO 2026-07-09 B382SD484690 Surgical Direct Surgical Direct, Inc. FFO 2026-07-09 B382SD484700 Surgical Direct Surgical Direct, Inc. FFO 2026-07-09 B382SD484710 Surgical Direct Surgical Direct, Inc. FFO 2026-07-09 B382SD484720 Surgical Direct Surgical Direct, Inc. FFO 2026-07-09 B382SD9147091620 Surgical Direct Surgical Direct, Inc. FFO 2026-07-09 09348811114068 INKA The Trustee for KAISER FAMILY TRUST FFO 2026-05-29 09348811114075 INKA The Trustee for KAISER FAMILY TRUST FFO 2026-05-29 B382SD915097010 Surgical Direct Surgical Direct, Inc. FFO 2026-02-09 09348811023612 INKA The Trustee for KAISER FAMILY TRUST FFO 2025-11-19 07898506813698 Quinelato Schobell Industrial Ltda FFO 2022-12-16 B382SD907632000 Surgical Direct Surgical Direct, Inc. FFO 2022-12-02 B382SD9228621010 Surgical Direct Surgical Direct, Inc. FFO 2022-12-01 00192896094710 INGE LAMINA SPREADER RETRACTOR SONTEC INSTRUMENTS, INC. FFO 2019-03-07 10381780268437 Omni-Tract® INTEGRA LIFESCIENCES CORPORATION FFO 2018-10-23 10381780268420 Omni-Tract® INTEGRA LIFESCIENCES CORPORATION FFO 2018-05-03 10381780268499 Omni-Tract® INTEGRA LIFESCIENCES CORPORATION FFO 2018-05-03 10381780269397 Omni-Tract® INTEGRA LIFESCIENCES CORPORATION FFO 2018-05-03 10381780269427 Omni-Tract® INTEGRA LIFESCIENCES CORPORATION FFO 2018-05-03 10381780269489 Omni-Tract® INTEGRA LIFESCIENCES CORPORATION FFO 2018-05-03 10381780269564 Omni-Tract® INTEGRA LIFESCIENCES CORPORATION FFO 2018-05-03 10381780269663 Omni-Tract® INTEGRA LIFESCIENCES CORPORATION FFO 2018-05-03
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