Navilyst Medical
GUDID H965459001
MiniStick II Microintroducer Kit 4F, Tearaway Sheath/Dilator
Angiodynamics, Inc.
Vascular catheter introduction set, nonimplantable| Primary Device ID | H965459001 |
| NIH Device Record Key | 1091439e-5a6f-4e32-a110-846388334dfd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Navilyst Medical |
| Version Model Number | 45-900 |
| Company DUNS | 079252781 |
| Company Name | Angiodynamics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com | |
| Phone | +1(800)772-6446 |
| customerservice@angiodynamics.com |
Device Dimensions
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Gauge | 4 French |
| Catheter Length | 7 Centimeter |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Gauge | 4 French |
| Catheter Length | 7 Centimeter |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Gauge | 4 French |
| Catheter Length | 7 Centimeter |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Gauge | 4 French |
| Catheter Length | 7 Centimeter |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Gauge | 4 French |
| Catheter Length | 7 Centimeter |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Gauge | 4 French |
| Catheter Length | 7 Centimeter |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Gauge | 4 French |
| Catheter Length | 7 Centimeter |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Gauge | 4 French |
| Catheter Length | 7 Centimeter |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Gauge | 4 French |
| Catheter Length | 7 Centimeter |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Gauge | 4 French |
| Catheter Length | 7 Centimeter |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Gauge | 4 French |
| Catheter Length | 7 Centimeter |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Gauge | 4 French |
| Catheter Length | 7 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H965459000 [Primary] |
| HIBCC | H965459001 [Package] Contains: H965459000 Package: Box [5 Units] In Commercial Distribution |
FDA Product Code
| OFL | Percutaneous Sheath Introducer Kit |
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 | 2024-10-29 |
| Device Publish Date | 2024-10-21 |
On-Brand Devices [Navilyst Medical]
| H965459181 | MiniStick II Microintroducer Kit 3F, Peelable Sheath/Dilator, 45cm Nitinol/SS Guidewire |
| H965459171 | MiniStick II Microintroducer Kit 6F, 45cm Nitinol/SS Wire |
| H965459161 | MiniStick II Microintroducer Kit 5F, 45cm Nitinol/SS Wire |
| H965459151 | MiniStick II Microintroducer Kit 4F, 45cm Nitinol/SS Wire |
| H965459021 | MiniStick II Microintroducer Kit 6F, Tearaway Sheath/Dilator |
| H965459011 | MiniStick II Microintroducer Kit 5F, Tearaway Sheath/Dilator |
| H965459001 | MiniStick II Microintroducer Kit 4F, Tearaway Sheath/Dilator |
Trademark Results [Navilyst Medical]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NAVILYST MEDICAL 85054172 3907588 Live/Registered |
Navilyst Medical, Inc. 2010-06-03 |
 NAVILYST MEDICAL 77498811 3719467 Live/Registered |
NAVILYST MEDICAL, INC. 2008-06-13 |
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