Home GUDID 00850458007041 GripTract-GI Endoscopic Tissue Manipulator
Primary DI 00850458007041
Brand GripTract-GI Endoscopic Tissue Manipulator
Company ACTUATED MEDICAL, INC.
Model GT-101
Device description GripTract Model 101 is a single use, non-sterile, endoscope accessory intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment. GripTract Model 101 is indicated for use in the large intestine with any standard endoscope that has a distal tip outer diameter of 11.5 - 12.0 mm and a working length of 168 - 170 cm.
Published 2025-01-16
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true
Product Codes# Code, Name table Code Name FDF Colonoscope And Accessories, Flexible/Rigid
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10850458007048 Package GS1 5 Not in Commercial Distribution 00850458007041 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 10850458007048 10850458007048 00850458007041 00850458007041 850458007041 0850458007041
GMDN Terms# Term, Definition table Term Definition Externally-mounted endoscopic tissue manipulator A non-powered manual surgical instrument designed to be externally-mounted onto a gastrointestinal endoscope to assist intraoperative manoeuvring of the distal end of endoscopic instruments (e.g., electrosurgical electrode), and atraumatically retract, grasp and manipulate tissue to optimise site access and visualization during endoscopic surgery; it may also be used to remove foreign bodies. It has integrated distal finger-like effectors, long flexible extraluminal shafts, and proximal rotational and translational knob controls; unlike endoscopic forceps it is not designed with hinged jaws. It is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.
Regulatory Flags# DUNS number 791379030 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08809882470213 ROBOPERA™ SET EndoRobotics Co., Ltd. FDF 2026-10-16 08809882470220 Articulated Basic Gripper G EndoRobotics Co., Ltd. FDF 2026-10-16 08809882470237 Articulated Dual Gripper G EndoRobotics Co., Ltd. FDF 2026-10-16 08809882470381 ROBOPERA™ Unit EndoRobotics Co., Ltd. FDF 2026-10-16 08809882470398 ROBOPERA™ EndoRobotics Co., Ltd. FDF 2026-10-16 08809882470404 Controller A EndoRobotics Co., Ltd. FDF 2026-10-16 08809882470428 Controller B EndoRobotics Co., Ltd. FDF 2026-10-16 08809882470442 ROBOPERA™ Accessories EndoRobotics Co., Ltd. FDF 2026-10-16 08809882470466 R-Power Cable EndoRobotics Co., Ltd. FDF 2026-10-16 08809882470725 ROBOPERA™ Storage Case EndoRobotics Co., Ltd. FDF 2026-10-16 04580826920035 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25 04580826920066 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25 04580826920141 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25 04580826920271 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25 04580826920295 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25 04580826920394 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25 04580826920462 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25 04580826921599 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25 04580826921742 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25 04580826921759 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25 04580826922176 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25 04580826922183 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25 04580826922190 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25 04580826925672 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25 04580826925702 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25 04580826925832 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25 04580826926068 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25 04580826926075 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25 04580826926082 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25 04580826926099 PENTAX Medical PENTAX MEDICAL CORPORATION FDF 2026-08-25