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Sklar®

FDA UDI

Class I (US FDA UDI)

by Sklar Corporation

Identity

Trade Name
Sklar® FDA UDI
Generic Name
Vaginal speculum, reusable FDA UDI
Device Name
CUSCO VAG SPEC SM 3 X 1.25" FDA UDI
Model / Reference
90-3957 FDA UDI
Description
CUSCO VAG SPEC SM 3 X 1.25" FDA UDI

Identifiers

Primary DI / UDI-DI
10649111253348 FDA UDI
FDA Product Code
HDF FDA UDI
GMDN Term
Vaginal speculum, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
884.4520 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

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Vaginal speculum, reusable

Sklar® by Sklar Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vaginal speculum, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sklar Corporation

Sources (1)

  • FDA UDI d0ec587f-07e1-420c-8c33-47eb800b7bc1 33 fields · synced Jun 8, 2026