← Back to catalogue

Papette

FDA UDI

Class II (US FDA UDI)

by Andwin Scientific

Identity

Trade Name
Papette FDA UDI
Generic Name
Cervical cytology brush FDA UDI
Device Name
PAPETTE PAP SMEAR BRUSH, NON-STERILE 8" (100) FDA UDI
Model / Reference
892030 FDA UDI
Description
PAPETTE PAP SMEAR BRUSH, NON-STERILE 8" (100) FDA UDI

Identifiers

Catalog Number
892030-P100 FDA UDI
Primary DI / UDI-DI
00187207000269 FDA UDI
510(k) Number
K983428 FDA UDI
FDA Product Code
HHT FDA UDI
GMDN Term
Cervical cytology brush 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cervical cytology brush

Papette by Andwin Scientific — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cervical cytology brush.

Cleared under the same submission

K983428 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Andwin Scientific

Sources (1)

  • FDA UDI 5f2264e6-995c-4480-a01d-9e11b7933ce8 35 fields · synced Jun 9, 2026