Identity
- Trade Name
- Gimmi FDA UDI
- Generic Name
- Surgical irrigation/aspiration cannula, non-illuminating, reusable FDA UDI
- Device Name
- ALPHADUR SUCTION / IRRIGATION SET Ø 2.8 MM, SLIDING VALVE WORKING LENGTH 300 MM FDA UDI
- Model / Reference
- T.0034.03 FDA UDI
- Description
- ALPHADUR SUCTION / IRRIGATION SET Ø 2.8 MM, SLIDING VALVE WORKING LENGTH 300 MM FDA UDI
Identifiers
- Catalog Number
- T.0034.03 FDA UDI
- Primary DI / UDI-DI
- 04049047630166 FDA UDI
- FDA Product Code
- OCX FDA UDI
- GMDN Term
- Surgical irrigation/aspiration cannula, non-illuminating, reusable 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Gimmi by Gimmi GmbH — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gimmi GmbH
Sources (1)
- FDA UDI c5b1967f-15eb-4aee-ab8b-462ec00c0049 36 fields · synced Jun 8, 2026