Home GUDID B354OS3 Reusable Handle - Tips 34mm
Primary DI B354OS3
Brand Reusable Handle - Tips 34mm
Company ORANGE SURGICAL INSTRUMENTS, LLC
Model B354OS3
Device description Reusable Handle - Tips 34mm
Published 2023-07-07
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 B354OS31 Primary HIBCC 0 B354OS32 Primary HIBCC 0 B354OS33 Primary HIBCC 0 B354OS34 Primary HIBCC 0 B354OS35 Primary HIBCC 0 B354OS39 Primary HIBCC 0 B354OS3 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Endoscopic electrosurgical handpiece/electrode, monopolar, reusable An electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.
Sterilization Methods# Method table Method Peracetic Acid
Regulatory Flags# DUNS number 047063695 Device count 99999 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B3543000011 ThoraClear Y Connector 3000-01 2025-11-25 B3543000012 ThoraClear Y Connector 3000-01 2025-11-25 B3543000013 ThoraClear Y Connector 3000-01 2025-11-25 B3543000014 ThoraClear Y Connector 3000-01 2025-11-25 B3543000015 ThoraClear Y Connector 3000-01 2025-11-25 B3543000019 ThoraClear Y Connector 3000-01 2025-11-25 B3543000010 ThoraClear Y Connector 3000-01 2025-11-25 B354OS3CDBK2 3 Ring Suture Passer - Bariatric OS3CDBK 2023-07-07 B354OS3CDBK3 3 Ring Suture Passer - Bariatric OS3CDBK 2023-07-07 B3541011 Duck Bill Forceps Inner Shaft 10mm 101 2023-07-19 B3541012 Duck Bill Forceps Inner Shaft 10mm 101 2023-07-19 B3541013 Duck Bill Forceps Inner Shaft 10mm 101 2023-07-19 B3541014 Duck Bill Forceps Inner Shaft 10mm 101 2023-07-19 B3541015 Duck Bill Forceps Inner Shaft 10mm 101 2023-07-19 B3541019 Duck Bill Forceps Inner Shaft 10mm 101 2023-07-19 B3541051 Biopsy Forceps Inner Shaft 10mm 105 2023-07-19 B3541052 Biopsy Forceps Inner Shaft 10mm 105 2023-07-19 B3541134 Biopsy Forceps with teeth Inner Shaft 113 2023-07-19 B3541135 Biopsy Forceps with teeth Inner Shaft 113 2023-07-19 B3541139 Biopsy Forceps with teeth Inner Shaft 113 2023-07-19
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