Home GUDID B177950134700 Accu-Beam
Primary DI B177950134700
Brand Accu-Beam
Company TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
Model 9501-34/70
Device description Fiber Director 34/70, 2.0mm ID
Published 2022-02-23
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 GEI Electrosurgical, Cutting & Coagulation & Accessories
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B177950134700 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition General/multiple surgical laser system beam guide, reusable A surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 130213366 Device count 1 DM exempt false Premarket exempt false 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 00190776402143 Millennium Avalign Technologies, Inc. GEI 2026-07-19 00198506092756 ELMED INCORPORATED ELMED INCORPORATED GEI 2026-07-17 00198506092923 ELMED INCORPORATED ELMED INCORPORATED GEI 2026-07-17 B382SD89239290 Surgical Direct Surgical Direct, Inc. GEI 2026-07-17 B382SD89509290 Surgical Direct Surgical Direct, Inc. GEI 2026-07-17 B382SD89529290 Surgical Direct Surgical Direct, Inc. GEI 2026-07-17 B382SD89759150 Surgical Direct Surgical Direct, Inc. GEI 2026-07-17 B382SD89819320 Surgical Direct Surgical Direct, Inc. GEI 2026-07-17 B382SD89839280 Surgical Direct Surgical Direct, Inc. GEI 2026-07-17 B382SD89839290 Surgical Direct Surgical Direct, Inc. GEI 2026-07-17 B382SD89914450 Surgical Direct Surgical Direct, Inc. GEI 2026-07-17 00190776398484 Millennium Avalign Technologies, Inc. GEI 2026-07-16 08800020100276 INTRAcel Tip Jeisys Medical Inc. GEI 2026-07-16 08800020100283 INTRAcel Tip Jeisys Medical Inc. GEI 2026-07-16 08800020100306 INTRAcel Tip Jeisys Medical Inc. GEI 2026-07-16 08800020100313 INTRAcel Tip Jeisys Medical Inc. GEI 2026-07-16 08800020100320 INTRAcel Tip Jeisys Medical Inc. GEI 2026-07-16 08800020100337 INTRAcel Tip Jeisys Medical Inc. GEI 2026-07-16 08800020104984 DENSITY Tip Jeisys Medical Inc. GEI 2026-07-16 08800020104991 DENSITY Tip Jeisys Medical Inc. GEI 2026-07-16 08800020105004 DENSITY Tip Jeisys Medical Inc. GEI 2026-07-16 08800020105059 DENSITY Tip Jeisys Medical Inc. GEI 2026-07-16 08800020105066 DENSITY Tip Jeisys Medical Inc. GEI 2026-07-16 08800020105073 DENSITY Tip Jeisys Medical Inc. GEI 2026-07-16 08800020106827 DENSITY Tip Jeisys Medical Inc. GEI 2026-07-16 08800020107626 DENSITY Handpiece Jeisys Medical Inc. GEI 2026-07-16 08800020107633 DENSITY Handpiece Jeisys Medical Inc. GEI 2026-07-16 08800020110565 INTRAcel Handpiece Jeisys Medical Inc. GEI 2026-07-16 08800020110572 INTRAcel Handpiece Jeisys Medical Inc. GEI 2026-07-16 08800020110640 Footswitch Jeisys Medical Inc. GEI 2026-07-16