Identity
- Trade Name
- VORTEX FDA UDI
- Generic Name
- Orthopaedic cement mixing bowl FDA UDI
- Device Name
- VORTEX VACUUM BOWL FDA UDI
- Model / Reference
- 71270068 FDA UDI
- Description
- VORTEX VACUUM BOWL FDA UDI
Identifiers
- Catalog Number
- 71270068 FDA UDI
- Primary DI / UDI-DI
- 03596010525550 FDA UDI
- FDA Product Code
- JDZ FDA UDI
- GMDN Term
- Orthopaedic cement mixing bowl FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4210 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic cement mixing bowl
Vortex by Smith & Nephew, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic cement mixing bowl.
- OPTIVAC FUSION — Biomet, Inc. · Class I
- Bioseal Inc. — BIOSEAL · Class I
- MectaCem Bowl — Tecres · Class I
- Mixing Bowl — IMEDICOM CO., LTD. · Class I
- BONE CEMENT CUP SPLITTER — BIOPRO, INC. · Class II
- BOWL AND SPATULA — Tecres · Class I
- MIXOR — Smith & Nephew, Inc. · Class I
- MIXOR — Smith & Nephew, Inc. · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 9e636cf7-219e-4392-964e-bf8a70516517 35 fields · synced Jun 6, 2026