U4 & 5R SWS DB/OM 18 D/G HK ROTH G-OFF BI 0/-7/+2

No Certificate FoundLegacy device

Snapshot 2026-11-02 · Link to EUDAMED

UDI-DI 00889989012552Basic UDI-DI B-00889989012552

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Class IIa · MDD (legacy) · Ormco Corporation

Identification

Model: 338-1510
EMDN: Q010403
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Manufacturer

Ormco Corporation

SRN US-MF-000038085

US · Brea

manufacturer

Authorised representative: KERR ITALIA SRL (IT-AR-000007600)

Related UDI-DIs

No other UDI-DIs share this Basic UDI-DI in this snapshot.

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/u4-5r-sws-db-om-18-d-g-hk-roth-g-off-bi-0-7-2-2552 · UDI page: /udi/00889989012552

All devices from Ormco Corporation