Strauss Surgical

FDA UDI

Class II (US FDA UDI)

by American Medical Endoscopy

Identity

Trade Name: Strauss Surgical FDA UDI
Generic Name: Flexible fibreoptic nasopharyngolaryngoscope FDA UDI
Model / Reference: STS-4032-300N FDA UDI

Identifiers

Primary DI / UDI-DI: 00851925007199 FDA UDI
510(k) Number: K083553 FDA UDI
FDA Product Code: EOB FDA UDI
GMDN Term: Flexible fibreoptic nasopharyngolaryngoscope 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

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

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Flexible fibreoptic nasopharyngolaryngoscope

Strauss Surgical by American Medical Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Flexible fibreoptic nasopharyngolaryngoscope.

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FIBER LARYNGOSCOPE — PENTAX of America, Inc. · 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: American Medical Endoscopy

Sources (1)

FDA UDI aa78ea03-8232-4bb8-a2ec-1275e0057837 33 fields · synced May 31, 2026