Optivisor Binocular Magnifier

FDA UDI

Class I (US FDA UDI)

by Sontec Instruments, Inc.

Identity

Trade Name: OPTIVISOR BINOCULAR MAGNIFIER FDA UDI
Generic Name: Surgical binoculars, reusable FDA UDI
Device Name: OPTIVISOR BINOCULAR MAGNIFIER #DA-7 FDA UDI
Model / Reference: 1103-4001 FDA UDI
Description: OPTIVISOR BINOCULAR MAGNIFIER #DA-7 FDA UDI

Identifiers

Catalog Number: 1103-4001 FDA UDI
Primary DI / UDI-DI: 00192896053144 FDA UDI
FDA Product Code: FSP FDA UDI
GMDN Term: Surgical binoculars, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

Sterilization Method

High-level Disinfectant FDA UDI

Category: Surgical binoculars, reusable

Optivisor Binocular Magnifier by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical binoculars, reusable.

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Brasseler USA — Peter Brasseler Holdings, LLC · Class I
Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
SuperVu XL Advantage 3.5x, at 34cm working distanc — Rudolf Riester GmbH & Co. KG · Class I
Surgical Telescope — Xenosys Co., Ltd. · Class I

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: Sontec Instruments, Inc.

Sources (1)

FDA UDI 911613b8-98ab-4d57-bedb-21348a146e78 36 fields · synced Jun 8, 2026