Identity
- Trade Name
- EleVation™ FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- EleVation™ Breast Biopsy System Introducer Stylet 12G FDA UDI
- Model / Reference
- EV12S FDA UDI
- Description
- EleVation™ Breast Biopsy System Introducer Stylet 12G FDA UDI
Identifiers
- Catalog Number
- EV12S FDA UDI
- Primary DI / UDI-DI
- 00801741182440 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
Dimensions & Sizes
- Size
- Needle Gauge — 12 Gauge FDA UDI
Category: Needle guide, single-use
EleVation™ by Bard Peripheral Vascular — 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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- 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
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
- Bard Peripheral Vascular
Sources (1)
- FDA UDI 44b94deb-1656-4d91-9fa6-7d2d06e178b9 36 fields · synced May 31, 2026