Home GUDID 16971381251613 Single-use Biopsy Forceps
Primary DI 16971381251613
Brand Single-use Biopsy Forceps
Company SCIVITA MEDICAL TECHNOLOGY CO., LTD.
Model BFTN-1811
Device description The single-use biopsy forceps has no physical or electrical connection to the endoscopic system and enters the human body through the instrument channel of the endoscope.
Published 2023-05-24
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name FCL Forceps, Biopsy, Non-Electric GCL Esophagoscope, General & Plastic Surgery HFB Forceps, Biopsy, Gynecological
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology 1 GCL Esophagoscope, General & Plastic Surgery Gastroenterology, Urology 2 HFB Forceps, Biopsy, Gynecological Obstetrics/Gynecology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 16971381251613 Package GS1 10 In Commercial Distribution 26971381251610 Package GS1 100 In Commercial Distribution 06971381251616 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 16971381251613 16971381251613 26971381251610 26971381251610 06971381251616 06971381251616 6971381251616
GMDN Terms# Term, Definition table Term Definition Flexible endoscopic biopsy forceps, single-use A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Handling Environment Humidity 20 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 40 Degrees Celsius Storage Environment Humidity 20 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Storage Environment Temperature -40 Degrees Celsius 55 Degrees Celsius
Regulatory Flags# DUNS number 544519831 Device count 1 DM exempt false Premarket exempt true 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 false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00724995346379 V. Mueller STERIS Deutschland GmbH FCL 2026-09-25 00724995346386 V. Mueller STERIS Deutschland GmbH FCL 2026-09-25 06934415023009 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415023467 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415023474 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024785 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024792 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024808 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024815 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024822 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024839 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024846 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024853 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024860 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024877 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024884 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024891 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024907 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024914 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024921 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024938 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024945 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024952 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024969 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024976 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024983 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415024990 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415025003 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415025010 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24 06934415025027 ZKSK Beijing ZKSK Technology Co.,Ltd FCL 2026-09-24