Home GUDID B504OM2321080 DePuy Mitek
Primary DI B504OM2321080
Brand DePuy Mitek
Company Provision
Model 232108
Published 2021-04-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name GES Blade, Scalpel LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GES Blade, Scalpel General, Plastic Surgery 1 LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B504OM2321080 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Carpal tunnel release instrument A sterile, hand-held, manual, surgical instrument designed for percutaneous or mini-open transection of the transverse carpal ligament for median nerve decompression. It typically consists of a tubular fenestrated probe that contains a wire with a toothed cutting segment, attached to a handle with a lever to extend and retract the wire. The probe is inserted through the carpal tunnel and the wire extended to expose the cutting section through the probe window, and distally through the skin so that it can be gripped to enable a manual sawing motion to transect the ligament. The probe may include a conductor for connecting to an external nerve-locating system. This is a single-use device.
Regulatory Flags# DUNS number 016889401 Device count 1 DM exempt true Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810055255184 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255191 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255207 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255214 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255238 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255245 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255252 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255269 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255276 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255283 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255290 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255313 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255320 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255337 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255368 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255382 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255429 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255436 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255443 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255450 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255467 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255474 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255511 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255528 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255535 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255542 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255559 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255566 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255580 Surgical Design Surgical Design, Inc. GES 2026-09-26 00810055255597 Surgical Design Surgical Design, Inc. GES 2026-09-26
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