Identity
- Trade Name
- iNSUFLOW SYNERGY XL PORT FDA UDI
- Generic Name
- Laparoscopic access cannula, single-use FDA UDI
- Device Name
- 10mm X 130mm GAS CONDITIONING PORT FDA UDI
- Model / Reference
- 1991-10B FDA UDI
- Description
- 10mm X 130mm GAS CONDITIONING PORT FDA UDI
Identifiers
- Catalog Number
- 1991-10B FDA UDI
- Primary DI / UDI-DI
- 00852588007137 FDA UDI
- FDA Product Code
- GCJ FDA UDIHIF FDA UDI
- GMDN Term
- Laparoscopic access cannula, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI884.1730 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 XL 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 b7edcd0e-a503-4914-bc85-819496ed8cb9 35 fields · synced May 30, 2026