← Back to catalogue

EleVation™

FDA UDI

Class II (US FDA UDI)

by Bard Peripheral Vascular

Identity

Trade Name
EleVation™ FDA UDI
Generic Name
Side-notch biopsy gun needle FDA UDI
Device Name
EleVation™ Breast Biopsy System Probe 12G FDA UDI
Model / Reference
EV12 FDA UDI
Description
EleVation™ Breast Biopsy System Probe 12G FDA UDI

Identifiers

Catalog Number
EV12 FDA UDI
Primary DI / UDI-DI
00801741182389 FDA UDI
FDA Product Code
KNW FDA UDI
GMDN Term
Side-notch biopsy gun needle 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
Length — 10 Centimeter FDA UDI
Needle Gauge — 12 Gauge FDA UDI

Category: Side-notch biopsy gun needle

EleVation™ by Bard Peripheral Vascular — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Side-notch biopsy gun needle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Bard Peripheral Vascular

Sources (1)

  • FDA UDI d1dbceea-f3c8-4fe7-8bde-012ddc031401 36 fields · synced Jun 8, 2026