Identity
- Trade Name
- S-Puller GI FDA UDI
- Generic Name
- Gastroduodenal motility analysis system FDA UDI
- Model / Reference
- S-Puller GI FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717775955726 FDA UDI
- FDA Product Code
- FFX FDA UDI
- GMDN Term
- Gastroduodenal motility analysis system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1725 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Gastroduodenal motility analysis system
The S-Puller GI is a comprehensive gastrointestinal motility analysis system designed to evaluate peristaltic motility in the stomach and/or small intestines. It features a monitor display, computer software, pressure catheter/probe, and pH electrode for measuring stomach acidity. The system is intended to predict gastric and duodenal ulcers and provide insights into gut function.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Medical Measurement Systems B.V.
Sources (1)
- FDA UDI 6e05ff3d-1746-463d-8ff8-6eabd43be0cd 32 fields · synced Jul 31, 2026