Vaxcel
GUDID 25051684020784
Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 4.5F x 10cm Dilator, NiTi Guidewire, and Radiopaque Tip
Angiodynamics, Inc.
Vascular catheter introduction set, nonimplantable| Primary Device ID | 25051684020784 |
| NIH Device Record Key | c9e0e039-54a5-4405-99bb-c2b76ed815ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vaxcel |
| Version Model Number | 45989 |
| Company DUNS | 079252781 |
| Company Name | Angiodynamics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
| Outer Diameter | 1.6 Millimeter |
| Lumen/Inner Diameter | 0.5 Millimeter |
| Length | 10 Centimeter |
| Catheter Gauge | 4.5 French |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051684020787 [Primary] |
| GS1 | 25051684020784 [Package] Contains: 15051684020787 Package: BX [10 Units] In Commercial Distribution |
| HIBCC | M001459890 [Previous] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K974640
FDA Product Code
| DRE | DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-28 |
| Device Publish Date | 2024-10-18 |
On-Brand Devices [Vaxcel]
| 25051684020821 | Vaxcel Mini Stick Kit Coaxial Dilator Set |
| 25051684020807 | Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 6F x 10cm Dilator, NiTi Guidewire, an |
| 25051684020791 | Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 5F x 10cm Dilator, NiTi Guidewire, an |
| 25051684020784 | Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 4.5F x 10cm Dilator, NiTi Guidewire, |
| 25051684020760 | Vaxcel Mini Stick Kit Coaxial Dilator Set |
| 25051684020753 | Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 6F x 10cm Dilator, and Radiopaque Tip |
| 25051684020746 | Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 5F x 10cm Dilator, and Radiopaque Tip |
Trademark Results [Vaxcel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VAXCEL 86303096 4671164 Live/Registered |
VAXCEL INTERNATIONAL CO., LTD. 2014-06-06 |
 VAXCEL 78387758 3319458 Live/Registered |
NAVILYST MEDICAL, INC. 2004-03-19 |
 VAXCEL 75592102 2669464 Live/Registered |
NAVILYST MEDICAL, INC. 1998-08-20 |
 VAXCEL 74358461 not registered Dead/Abandoned |
VAXCEL, INC. 1993-02-12 |
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