Identity
- Trade Name
- Velox Pro FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Model / Reference
- VP14100-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08055002900270 FDA UDI
- 510(k) Number
- K092338 FDA UDI
- FDA Product Code
- KNW FDA UDI
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1075 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Needle guide, single-use
Velox Pro by Medax Unipersonale Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Needle guide, single-use.
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- Sterile Disposable Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Coaxial needle — Möller Medical GmbH · Class II
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- InnoFine — JingFang Precision Medical Device(Shenzhen) Co., Ltd. · Class II
Cleared under the same submission
K092338 also covers:
- CUSTOMED — Customed, Inc.
- CUSTOMED — Customed, Inc.
- CUSTOMED — Customed, Inc.
- CUSTOMED — Customed, Inc.
- CUSTOMED — Customed, Inc.
- CUSTOMED — Customed, Inc.
- CUSTOMED — Customed, Inc.
- CUSTOMED — Customed, Inc.
- CUSTOMED — Customed, Inc.
- Caesar C — Medax Unipersonale Srl
- Caesar C — Medax Unipersonale Srl
- Caesar C — Medax Unipersonale Srl
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
- Medax Unipersonale Srl
Sources (1)
- FDA UDI fb11b4d1-78e7-4e7c-8b83-8dd125bf834e 33 fields · synced May 30, 2026