Home GUDID B382SD915097010 Surgical Direct
Primary DI B382SD915097010
Brand Surgical Direct
Company Surgical Direct, Inc.
Model SD91509701
Catalog number SD91509701
Device description O’Connor–O’Sullivan Abdominal Retractor, with 4" Deep Blades, 2ea 4.5cm x 10.6cm, 1ea 6.5cm x 10.3cm
Published 2026-02-09
Public version status Update
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 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 B382SD915097010 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Self-retaining surgical retractor, reusable A hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 124367223 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 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 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 10381780269670 Omni-Tract® INTEGRA LIFESCIENCES CORPORATION FFO 2018-05-03 10381780269694 Omni-Tract® INTEGRA LIFESCIENCES CORPORATION FFO 2018-05-03 10381780269724 Omni-Tract® INTEGRA LIFESCIENCES CORPORATION FFO 2018-05-03
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