Identity
- Trade Name
- INSUFLOW SYNERGY PORT FDA UDI
- Generic Name
- Laparoscopic access cannula, single-use FDA UDI
- Device Name
- 5mm GAS CONDITIONING PORT FDA UDI
- Model / Reference
- 1991 FDA UDI
- Description
- 5mm GAS CONDITIONING PORT FDA UDI
Identifiers
- Catalog Number
- 1991 FDA UDI
- Primary DI / UDI-DI
- 00852588007083 FDA UDI
- FDA Product Code
- HIF FDA UDIGCJ FDA UDI
- GMDN Term
- Laparoscopic access cannula, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1730 FDA UDI876.1500 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Ethylene Oxide FDA UDI
Insuflow Synergy Port by Lexion Medical LLC — 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
- Lexion Medical LLC
Sources (1)
- FDA UDI 8b9ad45d-347a-4463-8dde-ce4cb68fdcf5 35 fields · synced May 29, 2026