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 - Maxi, Esophageal FDA UDI
- Model / Reference
- ET2014 EUDAMEDFDA UDI
- Description
- Endoscopic Retrieval Net - Maxi, Esophageal FDA UDI
Identifiers
- Catalog Number
- ET2014 FDA UDI
- Primary DI / UDI-DI
- 00816207021119 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 — 160 Centimeter FDA UDIOuter Diameter — 3.0 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 e1dfd298-cd7d-44b5-a92c-7b85af44ee6d 61 fields · synced Jul 9, 2026
- FDA UDI 8c18903f-d5fe-4556-a46e-f02ceb1393e3 37 fields · synced May 30, 2026