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High Resolution Binocular Loupes Set

FDA UDI

Class I (US FDA UDI)

by Sontec Instruments, Inc.

Identity

Trade Name
HIGH RESOLUTION BINOCULAR LOUPES SET FDA UDI
Generic Name
Loupe FDA UDI
Device Name
HIGH RESOLUTION BINOCULAR LOUPES ON PROFESSIONAL L HEADBAND WITHOUT S-GUARD SET FDA UDI
Model / Reference
C-000.32.866 FDA UDI
Description
HIGH RESOLUTION BINOCULAR LOUPES ON PROFESSIONAL L HEADBAND WITHOUT S-GUARD SET FDA UDI

Identifiers

Catalog Number
C-000.32.866 FDA UDI
Primary DI / UDI-DI
00192896071476 FDA UDI
FDA Product Code
FSP FDA UDI
GMDN Term
Loupe 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Loupe

High Resolution Binocular Loupes Set by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Loupe.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sontec Instruments, Inc.

Sources (1)

  • FDA UDI b96f8090-66ed-4cda-b476-e370e34a1904 36 fields · synced May 30, 2026