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ClarusScope

FDA UDI

Class II (US FDA UDI)

by Clarus Medical, Llc

Identity

Trade Name
ClarusScope FDA UDI
Generic Name
Flexible fibreoptic intracranial/spinal endoscope FDA UDI
Device Name
Endoscope, Flexible Fiberoptic FDA UDI
Model / Reference
3000N FDA UDI
Description
Endoscope, Flexible Fiberoptic FDA UDI

Identifiers

Catalog Number
3000N FDA UDI
Primary DI / UDI-DI
B0673000N0 FDA UDI
510(k) Number
K942249 FDA UDI
FDA Product Code
GWG FDA UDI
GMDN Term
Flexible fibreoptic intracranial/spinal endoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1480 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

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Flexible fibreoptic intracranial/spinal endoscope

ClarusScope by Clarus Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible fibreoptic intracranial/spinal endoscope.

Cleared under the same submission

K942249 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clarus Medical, Llc

Sources (1)

  • FDA UDI 749a4446-92a2-4ad1-a103-79030fda7b91 36 fields · synced May 31, 2026