GripTract-GI Endoscopic Tissue Manipulator

GUDID 00850458007195

GripTract-GI Model GT-GS100 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 GT-GS100 is indicated for use in the upper gastrointestinal tract with any standard endoscope with a distal tip outer diameter of 9.8 – 10.5 mm and a working length of 103 -110 cm.

ACTUATED MEDICAL, INC.

Externally-mounted endoscopic tissue manipulator

• Primary Device ID: 00850458007195
• NIH Device Record Key: f971f374-6cd0-44e0-b6dd-bbd7647f600e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GripTract-GI Endoscopic Tissue Manipulator
• Version Model Number: GT-GS100
• Company DUNS: 791379030
• Company Name: ACTUATED MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850458007195 [Primary]
GS1	10850458007192 [Package]; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251041

FDA Product Code

• FDS: Gastroscope And Accessories, Flexible/Rigid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-31
• Device Publish Date: 2025-12-23

On-Brand Devices [GripTract-GI Endoscopic Tissue Manipulator]

• 00850458007041: GripTract Model 101 is a single use, non-sterile, endoscope accessory intended to assist in posi
• 00850458007195: GripTract-GI Model GT-GS100 is a single-use, non-sterile, endoscope accessory intended to assist