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Cytobrush Plus GT
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref C0104Model 70124-001Ref C0112Ref C0121Ref C0105
Identity
- Trade Name
- Cytobrush® Plus GT EUDAMEDCytobrush® Plus EUDAMEDCytobrush Plus GT FDA UDI
- Generic Name
- Cervical cytology brush FDA UDI
- Device Name
- Medscand® Sample Collection Kit EUDAMEDCytobrush® Plus GT, Sterile EUDAMEDGentle Touch Tip Cell Collector FDA UDI
- Model / Reference
- C0104 EUDAMEDFDA UDIC0105 EUDAMEDFDA UDIC0121 EUDAMEDFDA UDIC0112 EUDAMEDFDA UDI70124-001 EUDAMED
- Description
- Gentle Touch Tip Cell Collector FDA UDI
Identifiers
- Primary DI / UDI-DI
- 50888937003203 EUDAMEDFDA UDI50888937003210 EUDAMEDFDA UDI50888937003227 EUDAMEDFDA UDI00888937003284 EUDAMEDFDA UDI
- Basic UDI-DI
- 0888937TD006ns2S EUDAMED0888937TD006sYF 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 UDIEUDAMEDFDA 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 UDIFDA UDI
Manufacturing Date
No
FDA UDI
Category: Cervical cytology brush
Cytobrush Plus GT by CooperSurgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cervical cytology brush.
- Papette — Andwin Scientific · Class II
- Andwin Scientific — Andwin Scientific · Class II
- C60100 — B&B Company Co., Ltd. · Class II
- C60100 — B&B Company Co., Ltd. · Class II
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- SoftBiopsy — HISTOLOGICS LLC · Class I
- C20310 — B&B Company Co., Ltd. · Class II
- 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 Scored — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (8)
- FDA UDI d9ba7921-1aca-4b0f-b7bc-478ff6ed5904 34 fields · synced Jul 23, 2026
- FDA UDI e95fd96a-b9c9-4b58-bfae-80849213e5ab 34 fields · synced May 30, 2026
- FDA UDI 59163a2c-a1fa-4dad-91e2-4e9aa737a5d3 34 fields · synced May 30, 2026
- FDA UDI 5f2b12d6-c6dc-4c07-9dce-26cb04930d35 34 fields · synced May 30, 2026
- EUDAMED b3525990-47a5-49d7-b5d1-4f6f54bea1ad 61 fields · synced Jul 10, 2026
- EUDAMED c238ef66-bcd7-4ba4-adb1-1f7bdc7c6538 61 fields · synced Jul 16, 2026
- EUDAMED 2379fbde-429c-4aa8-afed-132206ea87fd 61 fields · synced Jul 17, 2026
- EUDAMED 222a2fd9-e667-4122-9232-9ce49f299444 61 fields · synced Jul 23, 2026