Home GUDID 09340254000632 TREWAVIS SURGICAL
Primary DI 09340254000632
Brand TREWAVIS SURGICAL
Company TREWAVIS SURGICAL INSTRUMENTS PTY LTD
Model SBT100
Catalog number 100-010-00
Device description MODEL TR RECTAL SUCTION BIOPSY TUBE (INSTRUMENT, BIOPSY, SUCTION) (Rectal Suction Biopsy Tool)
Published 2016-10-20
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 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 09340254000632 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 09340254000632 09340254000632 9340254000632
GMDN Terms# Term, Definition table Term Definition Open-surgery biopsy forceps, reusable A hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 746296651 Device count 1 Lot or batch true Serial number true Expiration date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 09340254029534 TREWAVIS SURGICAL 501-001-B 501-001-B 2025-06-05 09340254029541 TREWAVIS SURGICAL 501-001-G 501-001-G 2025-06-05 09340254029558 TREWAVIS SURGICAL 501-001-S 501-001-S 2025-06-05 09340254029442 TREWAVIS SURGICAL SBT 200 SBT 200 2022-10-13
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 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 CP12002 rbi2 suction rectal biopsy system AUS SYSTEMS PTY. LIMITED. FCK 2016-08-29