Home GUDID B3961501820 ESI
Primary DI B3961501820
Brand ESI
Company FTT MEDICAL, INC.
Model 15-0182
Device description "HIRSCHMAN ANOSCOPE, MEDIUM, 3/4"" X 2-3/4"". ACMI FITTING."
Published 2016-09-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name FER Anoscope And Accessories
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FER Anoscope And Accessories Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B3961501820 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Anoscope, reusable An endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. It is inserted into the body through the anus during anoscopy. The inserted portion is short in length, though longer than a sphincteroscope, and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are illuminated by a light source and can be viewed by the user through relayed lens optics or direct vision. This device is commonly used to examine/diagnose patients suffering pain in the rectum/anus, haemorrhoids, or anal fissures. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 002212793 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true 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 05060937770013 SleeveLUX 24 Anoscope/Proctoscope Haemoband Surgical FER 2026-04-28 05060937770020 SleeveLUX 16 Anoscope/Proctoscope Haemoband Surgical FER 2026-04-28 08033638802861 Self-light anoscopes SAPI MED SPA FER 2026-02-06 08033638802878 Self-light anoscopes SAPI MED SPA FER 2026-02-06 00860012876808 Air Assist GASTRO CONCEPTS LLC FER 2025-03-17 08051887044719 THD N-Ano anoscopes THD SPA FER 2025-03-14 08051887044733 THD N-Ano anoscope THD SPA FER 2025-03-14 08051887044757 THD N-Ano Anoscope THD SPA FER 2025-03-14 08051887044771 THD N-ano anoscope THD SPA FER 2025-03-14 18051887044730 THD N-Ano anoscope THD SPA FER 2025-03-14 18051887044754 THD N-Ano Anoscope THD SPA FER 2025-03-14 08033638801192 Adaptor SAPI MED SPA FER 2023-08-02 08033638800430 Self-light anoscopes SAPI MED SPA FER 2023-07-27 08033638800478 Self-light anoscopes SAPI MED SPA FER 2023-07-27 08033638800485 Self-light anoscopes SAPI MED SPA FER 2023-07-27 08033638801352 Epoflier SAPI MED SPA FER 2023-07-27 08033638802885 Self-light anoscopes SAPI MED SPA FER 2023-07-27 08033638800447 Self-light anoscopes SAPI MED SPA FER 2023-07-27 08033638803585 Self-light anoscopes SAPI MED SPA FER 2023-07-27 08033638801260 Self-light anoscopes SAPI MED SPA FER 2023-07-27 08033638801369 Epoflier SAPI MED SPA FER 2023-07-27 08033638802892 Self-light anoscopes SAPI MED SPA FER 2023-07-27 00732094007657 Welch Allyn, Inc. WELCH ALLYN, INC. FER 2023-04-27 00732094239331 Welch Allyn, Inc. WELCH ALLYN, INC. FER 2023-04-25 04053755200436 INSTRUMENT HEAD FOR UNISPEC TUBES Heine Optotechnik GmbH & Co. KG FER 2023-01-11 00732094007626 Welch Allyn, Inc. WELCH ALLYN, INC. FER 2021-05-07 00732094128208 Welch Allyn, Inc. WELCH ALLYN, INC. FER 2021-05-07 00732094007664 Welch Allyn, Inc. WELCH ALLYN, INC. FER 2021-04-26 00732094009828 Welch Allyn, Inc. WELCH ALLYN, INC. FER 2021-04-26 00732094007541 Welch Allyn, Inc. WELCH ALLYN, INC. FER 2021-04-15