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Cytobrush Plus GT Scored
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref C0305Model 70124-001
Identity
- Trade Name
- Cytobrush® Plus GT Scored EUDAMEDCytobrush Plus GT Scored FDA UDI
- Generic Name
- Cervical cytology brush FDA UDI
- Device Name
- Medscand® Sample Collection Kit EUDAMEDGentle touch tip cell collector FDA UDI
- Model / Reference
- C0305 EUDAMEDFDA UDI70124-001 EUDAMED
- Description
- Gentle touch tip cell collector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 50888937003234 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD006ns2S EUDAMED
- 510(k) Number
- K832986 FDA UDI
- FDA Product Code
- HHT FDA UDI
- EMDN Code
- W02020502 CERVICAL SCREENING SYSTEMS EUDAMED
- GMDN Term
- Cervical cytology brush FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4530 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cervical cytology brush
Cytobrush Plus GT Scored by CooperSurgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Cervical cytology brush.
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- Aero-Med — AERO-MED LLC · Class II
Cleared under the same submission
K832986 also covers:
- Cytobrush Plus — CooperSurgical, Inc.
- Cytobrush Plus — CooperSurgical, Inc.
- Cytobrush Plus — CooperSurgical, Inc.
- Cytobrush Plus — CooperSurgical, Inc.
- Cytobrush Plus GT — CooperSurgical, Inc.
- Medscand Pap-Perfect Supply Tray — CooperSurgical, Inc.
- Medscand Pap-Perfect Supply Tray — CooperSurgical, Inc.
- Medscand Pap-Perfect Supply Tray — CooperSurgical, Inc.
- Medscand Pap-Perfect Supply Tray — CooperSurgical, Inc.
- Medscand Pap-Perfect Supply Tray — CooperSurgical, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (2)
- FDA UDI eb1676ba-9c59-444a-8677-7f5c3edcb3f2 34 fields · synced Jun 20, 2026
- EUDAMED 3810dd86-5b15-409d-b558-7ad64b147bb5 61 fields · synced Jun 20, 2026