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Sinuscope

FDA UDI

Class II (US FDA UDI)

by Ecleris

Identity

Trade Name
SINUSCOPE FDA UDI
Generic Name
Rigid optical sinoscope FDA UDI
Device Name
SINUSCOPIO, 4 mm Ø , 70° , 185 mm HD FDA UDI
Model / Reference
R00 FDA UDI
Description
SINUSCOPIO, 4 mm Ø , 70° , 185 mm HD FDA UDI

Identifiers

Catalog Number
SN117 FDA UDI
Primary DI / UDI-DI
B366SN117 FDA UDI
510(k) Number
K030572 FDA UDI
FDA Product Code
EOB FDA UDI
GMDN Term
Rigid optical sinoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4760 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Rigid optical sinoscope

Sinuscope by Ecleris — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid optical sinoscope.

Cleared under the same submission

K030572 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ecleris

Sources (1)

  • FDA UDI 19aa7c63-19e8-4bad-9939-ab9f41474937 37 fields · synced Jun 8, 2026