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Insuflow Port 12mm Bariatric
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 4100-12B
Identity
- Trade Name
- Insuflow Port 12mm Bariatric EUDAMEDInsuflow Port FDA UDI
- Generic Name
- Laparoscopic access cannula, single-use FDA UDI
- Device Name
- Insuflow Port 12mm Bariatric EUDAMED12mm x 130mm Insuflow Port FDA UDI
- Model / Reference
- 4100-12B EUDAMEDFDA UDI
- Description
- 12mm x 130mm Insuflow Port FDA UDI
Identifiers
- Catalog Number
- 4100-12B FDA UDI
- Primary DI / UDI-DI
- 00852588007212 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00852588007212 EUDAMED
- 510(k) Number
- K170799 FDA UDI
- FDA Product Code
- HIF FDA UDIGCJ FDA UDIOSV FDA UDI
- EMDN Code
- K01010101 TROCAR STANDARD, SINGLE-USE EUDAMED
- GMDN Term
- Laparoscopic access cannula, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1730 FDA UDI876.1500 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 Port 12mm Bariatric by Lexion Medical LLC — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090456 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-00852588007212 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Lexion Medical LLC
- EUDAMED SRN
- US-MF-000033626
- Authorised Representative
- Donawa Lifescience Consulting Srl IT-AR-000007785
Sources (3)
- EUDAMED ab215138-db38-4604-997c-1b236838fb0f 61 fields · synced Aug 3, 2026
- FDA UDI 531d1348-9e13-4e3c-befd-9887d7252757 35 fields · synced May 30, 2026
- FDA 510(k) K090456 1 fields · synced May 18, 2026