Identity
- Trade Name
- GripTract-GI Endoscopic Tissue Manipulator FDA UDI
- Generic Name
- Externally-mounted endoscopic tissue manipulator FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- GT-101 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850458007041 FDA UDI
- 510(k) Number
- K231254 FDA UDI
- FDA Product Code
- FDF FDA UDI
- GMDN Term
- Externally-mounted endoscopic tissue manipulator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
GripTract-GI Endoscopic Tissue Manipulator by Actuated Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Actuated Medical, Inc.
Sources (1)
- FDA UDI c711221f-e5ee-46b0-9110-e882586c24c0 35 fields · synced May 29, 2026