PrimeSight

FDA UDI

Class II (US FDA UDI)

by SCHÖLLY FIBEROPTIC GmbH

Identity

Trade Name: PrimeSight FDA UDI
Generic Name: Rigid optical cystoscope FDA UDI
Device Name: Hysteroscope/Cystoscope 4 x 302 mm, 30° FDA UDI
Model / Reference: 08-4207 FDA UDI
Description: Hysteroscope/Cystoscope 4 x 302 mm, 30° FDA UDI

Identifiers

Primary DI / UDI-DI: 04250480106471 FDA UDI
FDA Product Code: HIH FDA UDI
FAJ FDA UDI
GMDN Term: Rigid optical cystoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1690 FDA UDI
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

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Rigid optical cystoscope

PrimeSight by SCHÖLLY FIBEROPTIC GmbH — 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
Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · 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

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: SCHÖLLY FIBEROPTIC GmbH

Sources (1)

FDA UDI 6dde5e4b-c95b-4dda-8ea3-b641df37386d 36 fields · synced May 30, 2026