GripTract-GI Endoscopic Tissue Manipulator

GUDID 00850458007041

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.

ACTUATED MEDICAL, INC.

Externally-mounted endoscopic tissue manipulator

• Primary Device ID: 00850458007041
• NIH Device Record Key: c711221f-e5ee-46b0-9110-e882586c24c0
• Commercial Distribution Discontinuation: 2025-04-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: GripTract-GI Endoscopic Tissue Manipulator
• Version Model Number: GT-101
• 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	00850458007041 [Primary]
GS1	10850458007048 [Package]; Package: Carton [5 Units]; Discontinued: 2025-04-10; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231254

FDA Product Code

• FDF: Colonoscope And Accessories, Flexible/Rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-04-10
• Device Publish Date: 2025-01-16

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