Home GUDID CP12002 rbi2 suction rectal biopsy system
Primary DI CP12002
Brand rbi2 suction rectal biopsy system
Company AUS SYSTEMS PTY. LIMITED.
Model rbi2
Catalog number CP1200
Device description rbi2 suction rectal biopsy capsules (10 procedure packs) to obtain a submucosal tissue specimen from the rectum.
Published 2016-08-29
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name FCK Instrument, Biopsy, Suction
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FCK Instrument, Biopsy, Suction Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status CP12002 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Rectal suction biopsy system An assembly of disposable and reusable devices designed to obtain a submucosal tissue specimen from the rectum using suction [rectal suction biopsy (RSB)], typically for histopathological analysis [e.g., to help diagnose Hirschsprung's disease (HD)]. It typically consists of dedicated disposable capsules (e.g., plastic cylinder-shaped devices with a small hole at their closed end that contain a metallic cutting blade), suction tubing with negative pressure manometers, and a reusable handpiece.
Sterilization Methods# Method table Method Radiation Sterilization
Regulatory Flags# DUNS number 755219508 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 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 B194SS10001 rbi2 suction rectal biopsy system rbi2 SS1000 2016-10-24 B194CP12001 rbi2 suction rectal biopsy system rbi2 CP1200 2016-08-29 B194HP10001 rbi2 suction rectal biopsy system rbi2 HP1000 2016-10-24 B194MR1001 rbi2 suction rectal biopsy system rbi2 MR100 2016-08-29 CP12000 rbi2 suction rectal biopsy system rbi2 CP1200 2016-08-29 CP12001 rbi2 suction rectal biopsy system rbi2 CP1200 2016-08-29
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00853277008084 LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) UVISION 360, INC. FCK 2021-08-13 00853277008091 LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) UVISION 360, INC. FCK 2021-08-13 B194HP10001 rbi2 suction rectal biopsy system AUS SYSTEMS PTY. LIMITED. FCK 2016-10-24 B194SS10001 rbi2 suction rectal biopsy system AUS SYSTEMS PTY. LIMITED. FCK 2016-10-24 09340254000632 TREWAVIS SURGICAL TREWAVIS SURGICAL INSTRUMENTS PTY LTD FCK 2016-10-20 00827002217911 Howell COOK INCORPORATED FCK 2016-09-24 B194CP12001 rbi2 suction rectal biopsy system AUS SYSTEMS PTY. LIMITED. FCK 2016-08-29 B194MR1001 rbi2 suction rectal biopsy system AUS SYSTEMS PTY. LIMITED. FCK 2016-08-29 CP12000 rbi2 suction rectal biopsy system AUS SYSTEMS PTY. LIMITED. FCK 2016-08-29 CP12001 rbi2 suction rectal biopsy system AUS SYSTEMS PTY. LIMITED. FCK 2016-08-29