Visi-Pro™
- Primary DI
- 00643169787742
- Brand
- Visi-Pro™
- Company
- Covidien LP
- Model
- PXB35-07-12-080
- Device description
- PXB35-07-12-080 STENT VISI PRO 035 V01
- Published
- 2018-09-09
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- Sterile
- true
- Single use
- true
Contact Domains#
medtronic.comProduct Codes#
Product Code Classifications#
Premarket Submissions#
| Submission | Supplement |
|---|---|
| P030045 | 002 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00643169787742 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00643169787742 | 00643169787742 | 643169787742 | 0643169787742 |
GMDN Terms#
| Term | Definition |
|---|---|
| Multiple peripheral artery stent, bare-metal | A sterile non-bioabsorbable tubular device intended to be alternatively implanted in more than one peripheral artery (e.g., iliac, carotid, renal) to indefinitely maintain patency and improve luminal diameter in patients with atherosclerotic disease or following the recanalization of a total occlusion. It is typically implanted by a dedicated instrument where it self-expands upon release or is balloon expanded. It is made of metal [e.g., nickel-titanium alloy (Nitinol)] and may be a continuous tube of a certain length, a mesh structure, or other design for supporting constant blood flow through the artery. Some types may be used in the biliary duct as a secondary intended use. |
Device Sizes#
| Type | Value | Unit |
|---|---|---|
| Catheter Gauge | 6 | French |
| Device Size Text, specify | 0 | |
| Length | 12 | Millimeter |
| Outer Diameter | 7 | Millimeter |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Special Storage Condition, Specify | 0 | 0 | Keep away from sunlight |
| Special Storage Condition, Specify | 0 | 0 | Keep dry |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)633-8766 | Corporate.UDI@medtronic.com |
Regulatory Flags#
- DUNS number
- 968903703
- Device count
- 1
- Lot or batch
- true
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|---|---|---|---|---|
| 10884521072602 | V-Loc | VLOCN204L | 2015-09-02 | |
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| 10884521091986 | Nellcor | SC-A-I | 2026-05-25 | |
| 10884521758803 | Vascufil | 8886470311V-2 | 2020-07-19 | |
| 10884521816312 | McGRATH MAC | 350-005-000 | 2021-10-21 | |
| 10884521816329 | McGRATH MAC | 350-013-000 | 2021-08-30 | |
| 10884521816336 | McGRATH MAC | 350-017-000 | 2021-10-18 | |
| 10884521816343 | McGRATH MAC | 350-072-000 | 2022-06-13 | |
| 10884521824317 | McGRATH MAC | 350-005-000 | 2022-09-25 | |
| 10884521824324 | McGRATH MAC | 350-013-000 | 2021-10-30 | |
| 10884521824331 | McGRATH MAC | 350-017-000 | 2021-08-26 | |
| 10884521824348 | McGRATH MAC | 350-072-000 | 2023-06-19 | |
| 10884521850118 | McGRATH MAC | 350-005-000 | 2025-04-27 | |
| 10884521850125 | McGRATH MAC | 350-013-000 | 2025-04-27 | |
| 10884521850132 | McGRATH MAC | 350-017-000 | 2025-04-27 | |
| 10884521850149 | McGRATH MAC | 350-072-000 | 2025-04-27 | |
| 15060272980310 | McGRATH MAC | 350-005-000 | 2021-08-02 | |
| 15060272980327 | McGRATH MAC | 350-013-000 | 2022-01-17 | |
| 15060272980334 | McGRATH MAC | 350-072-000 | 2021-04-18 | |
| 15060272980341 | McGRATH MAC | 350-017-000 | 2021-03-27 |
Other Devices Sharing Product Codes#
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|---|---|---|---|---|
| 15711055100400 | M-Drain | Mermaid Medical A/S | FGE | 2024-10-01 |
| 15711055110041 | M-Drain | Mermaid Medical A/S | FGE | 2024-07-20 |
| 15711055110409 | M-Drain | Mermaid Medical A/S | FGE | 2024-07-20 |
| 15711055120040 | M-Drain | Mermaid Medical A/S | FGE | 2024-01-31 |
| 15711055120453 | M-Drain | Mermaid Medical A/S | FGE | 2024-01-31 |
| 15711055000311 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000328 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000359 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000373 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000410 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000434 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
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| 15711055000472 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000496 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
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| 15711055000533 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000557 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
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| 15711055000595 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000625 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000632 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000663 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000670 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000700 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000724 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000748 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000762 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000779 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000809 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |
| 15711055000816 | M-Drain | Mermaid Medical A/S | FGE | 2016-09-24 |