Identity
- Trade Name
- BD SurePath FDA UDI
- Generic Name
- Endocervical specimen cytological examination kit IVD FDA UDI
- Device Name
- SurePath® GYN Preservative Vial Kit with Cervex-Brush Combi FDA UDI
- Model / Reference
- 491096 FDA UDI
- Description
- SurePath® GYN Preservative Vial Kit with Cervex-Brush Combi FDA UDI
Identifiers
- Catalog Number
- 491096 FDA UDI
- Primary DI / UDI-DI
- 00382904910969 FDA UDI
- PMA Number
- P970018 FDA UDI
- FDA Product Code
- MKQ FDA UDI
- GMDN Term
- Endocervical specimen cytological examination kit IVD FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not 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
Dimensions & Sizes
- Size
- Length — 44 Centimeter FDA UDIWidth — 44 Centimeter FDA UDIHeight — 37 Centimeter FDA UDI
BD SurePath by Becton Dickinson And Company — Class III — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
P970018 also covers:
- BD Density Reagent (480 ml) — BECTON DICKINSON AND COMPANY
- BD PrepMate™ Automated Accessory — BECTON DICKINSON AND COMPANY
- BD PrepMate™ Automated Accessory — BECTON DICKINSON AND COMPANY
- BD PrepMate™ Consumables Kit — BECTON DICKINSON AND COMPANY
- BD PrepStain Slide Processor — BECTON DICKINSON AND COMPANY
- BD PrepStain™ Consumables Kit — BECTON DICKINSON AND COMPANY
- BD SurePath™ Collection Vial — BECTON DICKINSON AND COMPANY
- BD SurePath™ GYN Preservative Vial Kit with Brush/Spatula — BECTON DICKINSON AND COMPANY
- BD SurePath™ GYN Preservative Vial Kit with Cervex-Brush — BECTON DICKINSON AND COMPANY
- BD SurePath™ GYN Preservative Vial Kit with Cervex-Brush Combi — BECTON DICKINSON AND COMPANY
- BD SurePath™ Manual Method Kit — BECTON DICKINSON AND COMPANY
- BD Syringing Pipettes — BECTON DICKINSON AND COMPANY
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class III | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (2)
- FDA UDI 354667ac-2d31-4b26-b199-7257e3c02a68 39 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 4, 2026