FDA UDI
In Commercial Distribution
🇺🇸 United States
EleVation™
DI: 00801741182396
·
Model: EV14
·
Bard Peripheral Vascular, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- EleVation™
- Primary DI
- 00801741182396
- Version / Model
- EV14
- Catalog Number
- EV14
- Company Name
- Bard Peripheral Vascular, Inc.
- Labeler DUNS
- 135057938
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-18
- Public Version
- 2
- Public Version Date
- 2020-07-10
- Public Version Status
- Update
- Public Device Record Key
- 97bc8d61-2c40-45fe-b9cd-1e7b0bd772a1
Device Description
EleVation™ Breast Biopsy System Probe 14G
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNW | INSTRUMENT, BIOPSY | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64328 | Side-notch biopsy gun needle | An invasive tubular surgical instrument designed to be connected to a biopsy gun handpiece (not included) for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It is a percutaneously-inserted needle with a side-notch cutter at the distal end which when activated causes a sharp, sliding cannula to slice a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741182393 | GS1 | CA | 5 | In Commercial Distribution | |
| Primary | 00801741182396 | GS1 |
Customer Contacts
- Phone
- +1(800)321-4254
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10 | Centimeter | |
| Needle Gauge | 14 | Gauge |