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Spatula

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name
Spatula FDA UDI
Generic Name
Cervical cytology scraper, single-use FDA UDI
Device Name
Medium, White for maximum cell pick-up in the detection of cervical cancer FDA UDI
Model / Reference
MX610 FDA UDI
Description
Medium, White for maximum cell pick-up in the detection of cervical cancer FDA UDI

Identifiers

Primary DI / UDI-DI
50888937001209 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cervical cytology scraper, single-use

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

Similar devices

Also classified as Cervical cytology scraper, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CooperSurgical, Inc.

Sources (1)

  • FDA UDI 5ac7e4df-07f4-4f19-9157-100478d3607f 33 fields · synced Jun 9, 2026