Roth Net 00711169
by US Endoscopy
Ref 00711169Model Roth Net Select - Sterile
Roth Net 00711169 is a device classified as Class I in the EU and Class II in the US made by US Endoscopy, registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI 0724995ENROTHNETSLTSLYN), cleared under FDA 510(k) K182909 on 21 Nov 2018 (1 earlier submission) and listed in FDA GUDID since 19 Mar 2020 (UDI-DI 00724995182762), active as of 24 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No date given
FDA recalls
None ongoingTrust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0724995ENROTHNETSLTSLYN 00724995182762 | Date20 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number00724995182762 | Date19 Mar 2020 | StatusListed |
| United States | FDA 510(k)SESE GUDID | NumberK182909 | Date21 Nov 2018 | StatusActive |
Official records
- EUDAMED public site 0724995ENROTHNETSLTSLYN
- AccessGUDID record 00724995182762
- FDA 510(k) database K182909
- FDA 510(k) database K122462
Across registries
- EUDAMED Basic UDI-DI 0724995ENROTHNETSLTSLYN registered 20 Oct 2026 Active
- FDA 510(k) K182909 decided 21 Nov 2018 Active
- FDA GUDID UDI-DI 00724995182762 listed 19 Mar 2020 Listed
Recalls
-
- Terminated Z-1416-2017
The firm was notified that the expiration date on the outer carton is different than the expiration date on the inner package. The expiration date is shorter than the actual expiration.
Timeline
- Cleared FDA 510(k) K122462
- Recall initiated FDA recalls Z-1416-2017
- Cleared FDA 510(k) K182909
- Listed FDA GUDID 00724995182762
- Registered EUDAMED 0724995ENROTHNETSLTSLYN
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- Roth Net
- Generic name
- Gastrointestinal/airway foreign body retrieval basket, single-use
- Device name
- Roth Net Select - Sterile
- Model / Ref / Catalog
- 00711169, Roth Net Select - Sterile
- Primary DI / UDI-DI
- 00724995182762
- Basic UDI-DI
- 0724995ENROTHNETSLTSLYN
- FDA product code
- GCJ, FDI
- EMDN code
- G0305010202 Digestive endoscopy, retrieval basket devices, non-revolving
- GMDN term
- Gastrointestinal/airway foreign body retrieval basket, single-use
- Device class
- Class I EUDAMEDClass II GUDID
- Regulation number
- 876.1500, 876.4300
- EU registration type
- Standard device
- EU market of registration
- Ireland
- GUDID distribution status
- In Commercial Distribution
- Size
- Outer Diameter — 2.5 MillimeterLength — 230 CentimeterWidth — 3 Centimeter
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device class | Class I | Class II |
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