Home GUDID M648C1002102 ONETRAC LX
Primary DI M648C1002102
Brand ONETRAC LX
Company OBP CORPORATION
Model C100210
Device description Retractor 135x30mm with Built-In Single-Use Multi-LED Light Source - STERILE
Published 2019-10-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true 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 M648C1002101 Package HIBCC 1 In Commercial Distribution M648C1002102 Package HIBCC 10 In Commercial Distribution M648C1002100 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Hand-held surgical retractor, single-use A hand-held, non-self-retaining 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 dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a single-use device.
Regulatory Flags# DUNS number 011560431 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 true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false 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