Fiber Intubation Scope

FDA UDI

Class I (US FDA UDI)

by PENTAX of America, Inc.

Identity

Trade Name: FIBER INTUBATION SCOPE FDA UDI
Generic Name: Flexible intubation laryngoscope, fibreoptic FDA UDI
Device Name: FIBEROPTICINTUBATIONSCOPE 2.6C 5.1TP ROP (USED) FDA UDI
Model / Reference: FI-16RBS FDA UDI
Description: FIBEROPTICINTUBATIONSCOPE 2.6C 5.1TP ROP (USED) FDA UDI

Identifiers

Primary DI / UDI-DI: 04961333240302 FDA UDI
FDA Product Code: CAL FDA UDI
GMDN Term: Flexible intubation laryngoscope, fibreoptic FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5530 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Flexible intubation laryngoscope, fibreoptic

Fiber Intubation Scope by PENTAX of America, Inc. — Class I — 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
DCI — Karl Storz GmbH & Co. KG · Class I
SOS Shikani Optical Stylet, Adult — CLARUS MEDICAL, LLC · Class II
PocketScope, pocket endoscope — CLARUS MEDICAL, LLC · Class II
TRACHEAL INTUBATION FIBERSCOPE — Olympus Medical Systems Corporation · Class II
TRACHEAL INTUBATION FIBERSCOPE — Olympus Medical Systems Corporation · Class II
SOS Shikani Optical Stylet, Pediatric — CLARUS MEDICAL, LLC · 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 I	Pending data

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Manufacturer

Manufacturer: PENTAX of America, Inc.

Sources (1)

FDA UDI 7bb4e99a-d4af-4b3a-a8ac-23ca71aaab0b 33 fields · synced May 31, 2026