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Sigma 250 Clip In Correction Frame

FDA UDI

Class I (US FDA UDI)

by Sontec Instruments, Inc.

Identity

Trade Name
SIGMA 250 CLIP IN CORRECTION FRAME FDA UDI
Generic Name
Loupe FDA UDI
Device Name
SIGMA 250 CLIP IN CORRECTION FRAME FOR PRESCRIPTION LENSES FDA UDI
Model / Reference
C-000.32.309 FDA UDI
Description
SIGMA 250 CLIP IN CORRECTION FRAME FOR PRESCRIPTION LENSES FDA UDI

Identifiers

Catalog Number
C-000.32.309 FDA UDI
Primary DI / UDI-DI
00192896071254 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

Sigma 250 Clip In Correction Frame 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 a4afd4e7-f509-43a8-907f-a593310750d4 35 fields · synced May 30, 2026