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Andwin Scientific

FDA UDI

Class II (US FDA UDI)

by Andwin Scientific

Identity

Trade Name
Andwin Scientific FDA UDI
Generic Name
Papanicolaou smear kit FDA UDI
Device Name
PAPKIT, 5012X, 1 Slide, Scraper, Swab & Fix Pouch FDA UDI
Model / Reference
230040 FDA UDI
Description
PAPKIT, 5012X, 1 Slide, Scraper, Swab & Fix Pouch FDA UDI

Identifiers

Primary DI / UDI-DI
00187207000177 FDA UDI
510(k) Number
K890283 FDA UDI
FDA Product Code
OHL FDA UDI
HHT FDA UDI
GMDN Term
Papanicolaou smear kit 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Papanicolaou smear kit

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

Similar devices

Also classified as Papanicolaou smear kit.

Cleared under the same submission

K890283 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Andwin Scientific

Sources (1)

  • FDA UDI 0a943800-c31d-4e89-a2b7-a9bd7edf4f55 34 fields · synced Jun 9, 2026