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 00190776417116 Millennium Avalign Technologies, Inc. GAD 2026-08-19 00190776417123 Millennium Avalign Technologies, Inc. GAD 2026-08-19 00190776426613 Millennium Avalign Technologies, Inc. GAD 2026-08-19 00190776426620 Millennium Avalign Technologies, Inc. GAD 2026-08-19 00190776417017 Millennium Avalign Technologies, Inc. GAD 2026-08-18 00190776417024 Millennium Avalign Technologies, Inc. GAD 2026-08-18 00190776417031 Millennium Avalign Technologies, Inc. GAD 2026-08-18 00190776425876 Millennium Avalign Technologies, Inc. GAD 2026-08-18 00190776426453 Millennium Avalign Technologies, Inc. GAD 2026-08-18 00198506093876 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-08-18 00198506093883 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-08-18 00198506093890 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-08-18 00198506093906 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-08-18 00198506093913 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-08-18 00198506093920 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-08-18 00198506093968 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-08-18 00198506093999 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-08-18 00198506094019 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-08-18 00198506094026 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-08-18 00198506094033 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-08-18 00198506094040 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-08-18 00198506094125 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-08-18 00198506094132 ELMED INCORPORATED ELMED INCORPORATED GAD 2026-08-18 00810130207459 MSI Modern Surgical Instruments LLC GAD 2026-08-18 00810130207466 MSI Modern Surgical Instruments LLC GAD 2026-08-18 00810130207473 MSI Modern Surgical Instruments LLC GAD 2026-08-18 00810130207480 MSI Modern Surgical Instruments LLC GAD 2026-08-18 00810130207497 MSI Modern Surgical Instruments LLC GAD 2026-08-18 00810130207503 MSI Modern Surgical Instruments LLC GAD 2026-08-18 00810130207510 MSI Modern Surgical Instruments LLC GAD 2026-08-18