Sklar Instruments

FDA UDI

Class I (US FDA UDI)

by Sklar Corporation

Identity

Trade Name: Sklar Instruments FDA UDI
Generic Name: Vaginal speculum, single-use FDA UDI
Device Name: ECONO STERILE PEDERSON SPEC STRL LG BX/50 FDA UDI
Model / Reference: 96-2616 FDA UDI
Description: ECONO STERILE PEDERSON SPEC STRL LG BX/50 FDA UDI

Identifiers

Primary DI / UDI-DI: 10649111069574 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Vaginal speculum, single-use

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

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Also classified as Vaginal speculum, single-use.

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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 4d0e23dd-c130-4702-bd0c-522824e6d4ef 33 fields · synced Jun 8, 2026