Symmetry Olsen

FDA UDI

Class II (US FDA UDI)

by Olsen Medical

Identity

Trade Name: Symmetry Olsen FDA UDI
Generic Name: Vaginal speculum, reusable FDA UDI
Model / Reference: 50102 FDA UDI

Identifiers

Catalog Number: 50102 FDA UDI
Primary DI / UDI-DI: 00841785107573 FDA UDI
510(k) Number: K922154 FDA UDI
FDA Product Code: HIB FDA UDI
GMDN Term: Vaginal speculum, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.4530 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Vaginal speculum, reusable

Symmetry Olsen by Olsen Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K922154 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Olsen Medical

Sources (1)

FDA UDI 790ed267-322e-4bdc-adc2-dfe75ad84b31 34 fields · synced Jun 1, 2026