Safetex

FDA UDI

Class II (US FDA UDI)

by Andwin Scientific

Identity

Trade Name: Safetex FDA UDI
Generic Name: Cervical cytology scraper, single-use FDA UDI
Device Name: SCRAPER, PLASTIC 8" SAFETEX DOUBLE ENDED (100) FDA UDI
Model / Reference: 890076 FDA UDI
Description: SCRAPER, PLASTIC 8" SAFETEX DOUBLE ENDED (100) FDA UDI

Identifiers

Primary DI / UDI-DI: 00187207000238 FDA UDI
510(k) Number: K983428 FDA UDI
FDA Product Code: HHT FDA UDI
GMDN Term: Cervical 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

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: Cervical cytology scraper, single-use

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

Similar devices

Also classified as Cervical cytology scraper, single-use.

ViaMed — RECE INTERNATIONAL CORP. · Class II
Spatula — CooperSurgical, Inc. · Class II
SpiraBrush CX — HISTOLOGICS LLC · Class I
6.5" Cytology Brush — TEAM TECHNOLOGIES, INC. · Class II
Cytology Brush — TEAM TECHNOLOGIES, INC. · Class II
Cytology Brush — TEAM TECHNOLOGIES, INC. · Class II
Spatula — CooperSurgical, Inc. · Class II

Cleared under the same submission

K983428 also covers:

Papette — Andwin Scientific
Papette — Andwin Scientific

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: Andwin Scientific

Sources (1)

FDA UDI dd066217-d2cf-4c30-8054-867a873997d2 34 fields · synced Jun 9, 2026