Home GUDID 00821925003729 USA Elite System
Primary DI 00821925003729
Brand USA Elite System
Company Gyrus ACMI, LLC
Model EVOR-26
Device description USA Elite System Standard Flow Resectoscope Visual Obturator 26 Fr, (8.7 mm) Color Coded White
Published 2016-10-14
Public version status Update
Distribution status Not 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 FAS ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00821925003729 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00821925003729 00821925003729 821925003729 0821925003729
GMDN Terms# Term, Definition table Term Definition Resectoscope An endoscope with a slender rigid inserted portion intended to be used to perform a resection (i.e., the electrosurgical removal of tissue within an organ). It is typically used for the transurethral resection of the prostate (TURP) for the treatment of benign prostatic hyperplasia (BPH) and removal of, e.g., myomas (fibroids) and polyps in the uterine cavity via the cervix. It typically consists of an outer sheath, a wide angle telescope, a working guide element and a variety of interchangeable electrosurgical electrodes such as a wire loop, knife, roller ball, ball and coagulating. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 007198742 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 true 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 00810143893137 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-21 00810143893144 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-21 00810143893151 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-21 00810143893168 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-21 00810143893175 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-21 00810143893182 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-21 00810143893199 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-21 00810143893205 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-21 00810143893212 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-21 00810143893229 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-21 00810143893236 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-21 00810143893243 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-21 00810143893250 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-21 00810143893267 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-21 00810143893274 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-21 00810143893281 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-21 00810143893298 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-21 00810143893304 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-21 00810143893311 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-21 00810143893007 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-20 00810143893014 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-20 00810143893021 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-20 00810143893038 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-20 00810143893045 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-20 00810143893052 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-20 00810143893069 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-20 00810143893076 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-20 00810143893083 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-20 00810143893090 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-20 00810143893106 Strauss Surgical AMERICAN MEDICAL ENDOSCOPY, INC. FAS 2026-07-20