Identity
- Trade Name
- SwirlNet EUDAMEDFDA UDI
- Generic Name
- Gastrointestinal/airway foreign body retrieval basket, single-use FDA UDI
- Device Name
- Endoscopic Retrieval Net (Non-Sterile) EUDAMEDEndoscopic Retrieval Net - Standard, Colonic FDA UDI
- Model / Reference
- ET2012 EUDAMEDFDA UDI
- Description
- Endoscopic Retrieval Net - Standard, Colonic FDA UDI
Identifiers
- Catalog Number
- ET2012 FDA UDI
- Primary DI / UDI-DI
- 00816207021096 EUDAMEDFDA UDI
- Basic UDI-DI
- 081620702nonsterilenetSV EUDAMED
- FDA Product Code
- FGX FDA UDI
- EMDN Code
- G0305010201 DIGESTIVE ENDOSCOPY, RETRIEVAL BASKET DEVICES, REVOLVING EUDAMED
- GMDN Term
- Gastrointestinal/airway foreign body retrieval basket, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.4730 FDA UDI
- Market of Registration
- Malta EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 230 Centimeter FDA UDIOuter Diameter — 2.5 Millimeter FDA UDI
SwirlNet by Endo-Therapeutics, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081620702nonsterilenetSV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Endo-Therapeutics Inc.
- EUDAMED SRN
- US-MF-000002267
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 29fa6abb-beb2-4c39-acb3-445581573ffc 61 fields · synced Jun 18, 2026
- FDA UDI 3a913193-9728-457d-9930-5822dc0e10fa 37 fields · synced May 30, 2026