No Certificate Found

Snapshot 2026-10-11 · Link to EUDAMED

Comfort Cool Gladiator Wrist & Thumb Orthosis, Small, Right

UDI-DI 00768627013789Basic UDI-DI 0768627ORTHO-4113-N9

Class I · MDR · North Coast Medical Inc.

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Identification

Model: 4113
EMDN: Y060613
Issuing agency: GS1
Device status: active
Sterile: No
Implantable: No
Measuring function: No
Reusable surgical: No

Certificates

No certificate found.

Snapshot 2026-10-11 · Link to EUDAMED

Manufacturer

North Coast Medical Inc.

SRN US-MF-000009087

US · Morgan Hill, California

manufacturer

Authorised representative: ICON (LR) Limited (IE-AR-000006507)

Related UDI-DIs

Comfort Cool Gladiator Wrist & Thumb, Large, Left 00768627013819
Comfort Cool Gladiator Wrist & Thumb, Large, Right 00768627013826
Comfort Cool Gladiator Wrist & Thumb Orthosis, Medium, Left 00768627013796
Comfort Cool Gladiator Wrist & Thumb Orthosis, Medium, Right 00768627013802
Comfort Cool Gladiator Wrist & Thumb Orthosis, Small, Left 00768627013772
Comfort Cool Gladiator Wrist & Thumb, X-Large, Left 00768627013833
Comfort Cool Gladiator Wrist & Thumb, X-Large, Right 00768627013840
Comfort Cool Gladiator Wrist & Thumb, XX-Large, Left 00768627014779
Comfort Cool Gladiator Wrist & Thumb, XX-Large Right 00768627014892

All UDI-DIs in this Basic UDI-DI family

Canonical device page: /device/comfort-cool-gladiator-wrist-thumb-orthosis-small-right-3789 · UDI page: /udi/00768627013789

All devices from North Coast Medical Inc.

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