Identity
- Trade Name
- Medscand® Sample Collection Kit FDA UDI
- Generic Name
- Urogenital specimen collection kit IVD, clinical FDA UDI
- Device Name
- Medscand® Sample Collection Kit for use with The ThinPrep® Pap Test™ Cytobrush® Plus GT • Pap-Perfect® Plastic Spatula FDA UDI
- Model / Reference
- 02500 FDA UDI
- Description
- Medscand® Sample Collection Kit for use with The ThinPrep® Pap Test™ Cytobrush® Plus GT • Pap-Perfect® Plastic Spatula FDA UDI
Identifiers
- Primary DI / UDI-DI
- 60888937010956 FDA UDI
- 510(k) Number
- K861389 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Urogenital specimen collection kit IVD, clinical
Medscand® Sample Collection Kit 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
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 134ed6e4-a7ab-4eed-ab79-16ce25105692 34 fields · synced Jun 9, 2026