Identity
- Trade Name
- Polygraf ID FDA UDI
- Generic Name
- Manometric gastrointestinal motility analysis system FDA UDI
- Device Name
- A500 Module FDA UDI
- Model / Reference
- 9043G0133 FDA UDI
- Description
- A500 Module FDA UDI
Identifiers
- Catalog Number
- 9043G0133 FDA UDI
- Primary DI / UDI-DI
- 07290101363330 FDA UDI
- FDA Product Code
- MYE FDA UDI
- GMDN Term
- Manometric gastrointestinal motility analysis system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1735 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Polygraf ID by Given Imaging , Ltd. — 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
- Given Imaging , Ltd.
Sources (1)
- FDA UDI 36e0a225-6b01-4a2c-a9c3-6738e3e3573c 37 fields · synced May 29, 2026