FDA UDI
Not in Commercial Distribution
🇺🇸 United States
GripTract-GI Endoscopic Tissue Manipulator
DI: 00850458007041
·
Model: GT-101
·
ACTUATED MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GripTract-GI Endoscopic Tissue Manipulator
- Primary DI
- 00850458007041
- Version / Model
- GT-101
- Company Name
- ACTUATED MEDICAL, INC.
- Labeler DUNS
- 791379030
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-16
- Public Version
- 2
- Public Version Date
- 2025-04-10
- Public Version Status
- Update
- Public Device Record Key
- c711221f-e5ee-46b0-9110-e882586c24c0
- Distribution End Date
- 2025-04-10
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FDF | Colonoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67415 | 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850458007041 | GS1 | ||||
| Package | 10850458007048 | GS1 | Carton | 5 | Not in Commercial Distribution | 2025-04-10 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K231254 | 000 |