Papette

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name: Papette FDA UDI
Generic Name: Cytology scraper, single-use FDA UDI
Device Name: WALLACH Papette® (Non-Sterile) For Cervical Cytology utilizing the Conventional Pap Smear FDA UDI
Model / Reference: 908001 FDA UDI
Description: WALLACH Papette® (Non-Sterile) For Cervical Cytology utilizing the Conventional Pap Smear FDA UDI

Identifiers

Primary DI / UDI-DI: 50888937011277 FDA UDI
510(k) Number: K896065 FDA UDI
FDA Product Code: HHT FDA UDI
GMDN Term: Cytology scraper, 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

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Cytology scraper, single-use

Papette by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K896065 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: CooperSurgical, Inc.

Sources (1)

FDA UDI 1a678d1a-51bd-42ef-9e29-b6d076923cd0 34 fields · synced Jun 9, 2026