Century Uterine Manipulator

FDA UDI

Class II (US FDA UDI)

by Gynex Corporation

Identity

Trade Name: Century Uterine Manipulator FDA UDI
Generic Name: Uterine manipulator, single-use FDA UDI
Model / Reference: 10-160 FDA UDI

Identifiers

Primary DI / UDI-DI: GYNX101601 FDA UDI
510(k) Number: K022503 FDA UDI
FDA Product Code: LKF FDA UDI
GMDN Term: Uterine manipulator, single-use 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

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Uterine manipulator, single-use

Century Uterine Manipulator by Gynex Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Gynex Corporation

Sources (1)

FDA UDI db02edbd-75b3-4b5f-9180-80f6b4f26d8d 33 fields · synced May 30, 2026