Her Option

FDA UDI

Class III (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name: Her Option FDA UDI
Generic Name: Hand-held cryosurgical system handpiece tip FDA UDI
Device Name: Her Option Disposable Probe FDA UDI
Model / Reference: CU-1 FDA UDI
Description: Her Option Disposable Probe FDA UDI

Identifiers

Primary DI / UDI-DI: 20888937000027 FDA UDI
PMA Number: P000032 FDA UDI
FDA Product Code: MNB FDA UDI
GMDN Term: Hand-held cryosurgical system handpiece tip FDA UDI

Classification

Device Class: Class III 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Hand-held cryosurgical system handpiece tip

Her Option by CooperSurgical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

P000032 also covers:

Her Option — CooperSurgical, Inc.

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 III	Pending data

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Manufacturer

Manufacturer: CooperSurgical, Inc.

Sources (1)

FDA UDI da942d3c-220d-4bac-bbab-7194211fc06a 34 fields · synced Jun 9, 2026