Identity
- Trade Name
- Hasson FDA UDI
- Generic Name
- Laparoscopic access cannula anchor, single-use FDA UDI
- Model / Reference
- 400-012-131 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00877972000563 FDA UDI
- 510(k) Number
- K982472 FDA UDI
- FDA Product Code
- GEA FDA UDI
- GMDN Term
- Laparoscopic access cannula anchor, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- 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
No
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
Category: Laparoscopic access cannula anchor, single-use
Hasson by Genicon — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Laparoscopic access cannula anchor, single-use.
- TiLink-P Screw 12mm x 30mm — SURGENTEC LLC · Class II
- Thoracoport — Covidien LP · Class II
- TiLink-P Anchor — SURGENTEC LLC · Class II
- TiLink-P Screw 12mm x 25mm — SURGENTEC LLC · Class II
- TiLink-L Implant 35mm x 10mm — SURGENTEC LLC · Class II
- TiLink-L Implant 30mm x 10mm — SURGENTEC LLC · Class II
- Thoracoport — Covidien LP · Class II
- Thoracoport — Covidien LP · Class II
Cleared under the same submission
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 I | Pending data |
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Manufacturer
- Manufacturer
- Genicon
Sources (1)
- FDA UDI 48da7691-b2a5-479e-bcd1-2dbf4306805e 33 fields · synced May 30, 2026