Home GUDID M648C1002601 ONETRAC LX
Primary DI M648C1002601
Brand ONETRAC LX
Company OBP CORPORATION
Model C100260
Device description Retractor 135X60mm with Built-In Single-Use Multi-LED Light Source - STERILE
Published 2020-04-22
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 M648C1002601 Package HIBCC 1 In Commercial Distribution M648C1002602 Package HIBCC 10 In Commercial Distribution M648C1002600 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 00190776422615 Millennium Avalign Technologies, Inc. GAD 2026-08-03 00190776422691 Millennium Avalign Technologies, Inc. GAD 2026-08-03 00190776422707 Millennium Avalign Technologies, Inc. GAD 2026-08-03 00190776422714 Millennium Avalign Technologies, Inc. GAD 2026-08-03 00190776422776 Millennium Avalign Technologies, Inc. GAD 2026-08-03 00190776422882 Millennium Avalign Technologies, Inc. GAD 2026-08-03 00190776422905 Millennium Avalign Technologies, Inc. GAD 2026-08-03 00190776422264 Millennium Avalign Technologies, Inc. GAD 2026-07-31 00190776422288 Millennium Avalign Technologies, Inc. GAD 2026-07-31 00190776422301 Millennium Avalign Technologies, Inc. GAD 2026-07-31 00190776422530 Millennium Avalign Technologies, Inc. GAD 2026-07-31 00190776422547 Millennium Avalign Technologies, Inc. GAD 2026-07-31 00190776422554 Millennium Avalign Technologies, Inc. GAD 2026-07-31 00190776422561 Millennium Avalign Technologies, Inc. GAD 2026-07-31 00190776422578 Millennium Avalign Technologies, Inc. GAD 2026-07-31 B382S349571000 Surgical Direct Surgical Direct, Inc. GAD 2026-07-31 00199150083107 Medtronic Reusable Instruments MEDTRONIC SOFAMOR DANEK, INC. GAD 2026-07-30 00199150083879 Medtronic Reusable Instruments MEDTRONIC SOFAMOR DANEK, INC. GAD 2026-07-30 00810143904659 SURGIPROS Surgipros, LLC GAD 2026-07-30 00810143904680 SURGIPROS Surgipros, LLC GAD 2026-07-30 00810143904697 SURGIPROS Surgipros, LLC GAD 2026-07-30 00810143904703 SURGIPROS Surgipros, LLC GAD 2026-07-30 00810143904710 SURGIPROS Surgipros, LLC GAD 2026-07-30 00810143904727 SURGIPROS Surgipros, LLC GAD 2026-07-30 00810143904918 SURGIPROS Surgipros, LLC GAD 2026-07-30 00810143904925 SURGIPROS Surgipros, LLC GAD 2026-07-30 00810143904932 SURGIPROS Surgipros, LLC GAD 2026-07-30 00810143904949 SURGIPROS Surgipros, LLC GAD 2026-07-30 00810143904956 SURGIPROS Surgipros, LLC GAD 2026-07-30 00810143905045 SURGIPROS Surgipros, LLC GAD 2026-07-30