Strauss Surgical

FDA UDI

Class II (US FDA UDI)

by American Medical Endoscopy

Identity

Trade Name: Strauss Surgical FDA UDI
Generic Name: Rigid optical cystoscope FDA UDI
Model / Reference: STS-2040-302ESA FDA UDI

Identifiers

Primary DI / UDI-DI: 00851925007410 FDA UDI
FDA Product Code: FAJ FDA UDI
GMDN Term: Rigid optical cystoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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: Rigid optical cystoscope

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

Similar devices

Also classified as Rigid optical cystoscope.

Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II
AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
IEC-Innoview GmbH — INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C. · Class II
AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: American Medical Endoscopy

Sources (1)

FDA UDI b9b4c230-2511-41c5-9a14-2b03ba4db494 32 fields · synced Jun 8, 2026