SOS Shikani Optical Stylet, Pediatric

FDA UDI

Class II (US FDA UDI)

by Clarus Medical, Llc

Identity

Trade Name: SOS Shikani Optical Stylet, Pediatric FDA UDI
Generic Name: Flexible intubation laryngoscope, fibreoptic FDA UDI
Device Name: SOS Shikani Optical Stylet, Pediatric FDA UDI
Model / Reference: 30001-10 FDA UDI
Description: SOS Shikani Optical Stylet, Pediatric FDA UDI

Identifiers

Catalog Number: 30001-10 FDA UDI
Primary DI / UDI-DI: B06730001100 FDA UDI
FDA Product Code: EOB FDA UDI
GMDN Term: Flexible intubation laryngoscope, fibreoptic 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

High-level Disinfectant FDA UDI

Category: Flexible intubation laryngoscope, fibreoptic

SOS Shikani Optical Stylet, Pediatric by Clarus Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible intubation laryngoscope, fibreoptic.

DCI — Karl Storz GmbH & Co. KG · Class I
TRACHEAL INTUBATION FIBERSCOPE — Olympus Medical Systems Corporation · Class II
FIBER INTUBATION SCOPE — PENTAX of America, Inc. · Class I
FIBER INTUBATION SCOPE — PENTAX of America, Inc. · Class I
DCI — Karl Storz GmbH & Co. KG · Class I
FIBER INTUBATION SCOPE — PENTAX of America, Inc. · Class I
FIBER INTUBATION SCOPE — PENTAX of America, Inc. · Class I
TRACHEAL INTUBATION FIBERSCOPE — Olympus Medical Systems Corporation · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Clarus Medical, Llc

Sources (1)

FDA UDI 0e07e838-f6cb-49db-b096-15c10f3cd68b 35 fields · synced May 30, 2026