Identity
- Trade Name
- Medscand Pap-Perfect Supply Tray FDA UDI
- Generic Name
- Urogenital specimen collection kit IVD, clinical FDA UDI
- Device Name
- Cytobrush Plus FDA UDI
- Model / Reference
- 10115-20/50 FDA UDI
- Description
- Cytobrush Plus FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937009936 FDA UDI
- 510(k) Number
- K832986 FDA UDI
- FDA Product Code
- HHT FDA UDI
- GMDN Term
- Urogenital specimen collection kit IVD, clinical 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urogenital specimen collection kit IVD, clinical
Medscand Pap-Perfect Supply Tray by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urogenital specimen collection kit IVD, clinical.
- BD ProbeTec™ Qx Collection Kit for Endocervical or Lesion Specimens — BECTON DICKINSON AND COMPANY · Class II
- BD SurePath™ GYN Preservative Vial Kit with Brush/Spatula — BECTON DICKINSON AND COMPANY · Class III
- digene® HC2 DNA Collection Device — QIAGEN Sciences LLC · Class II
- Aptima® — Hologic, Inc. · Class II
- BD SurePath™ GYN Preservative Vial Kit with Cervex-Brush — BECTON DICKINSON AND COMPANY · Class III
- BD SurePath™ GYN Preservative Vial Kit with Cervex-Brush Combi — BECTON DICKINSON AND COMPANY · Class III
- BD Copan FLOQSwabs for HPV Self Collection — BECTON DICKINSON AND COMPANY · Class III
- Rapid fFN — Hologic, Inc. · Class I
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.
- 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.
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
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 891db3ac-b4dd-4dc5-84e4-921e8b6617a8 34 fields · synced Jun 9, 2026