Sklar®

FDA UDI

Class I (US FDA UDI)

by Sklar Corporation

Identity

Trade Name: Sklar® FDA UDI
Generic Name: Vaginal speculum, single-use FDA UDI
Device Name: GRAVES VAG SPEC M 1.25X4" BX12 FDA UDI
Model / Reference: 21-313 FDA UDI
Description: GRAVES VAG SPEC M 1.25X4" BX12 FDA UDI

Identifiers

Primary DI / UDI-DI: 40649111037680 FDA UDI
FDA Product Code: HDF FDA UDI
GMDN Term: Vaginal speculum, single-use 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Vaginal speculum, single-use

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

Similar devices

Also classified as Vaginal speculum, single-use.

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Vaginal Speculum — Dynarex Corp. · Class II
Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
Instraspec — ROBINSON HEALTHCARE LIMITED · Class II
ER-SPEC/OFFICE-SPEC — OBP CORPORATION · Class II
Bioseal Inc. — BIOSEAL · 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: Sklar Corporation

Sources (1)

FDA UDI 4cc52c1d-654c-4de0-8708-625a3c45c7ba 33 fields · synced Jun 8, 2026