| Primary Device ID | H965459021 |
| NIH Device Record Key | 8ec3c27e-23bf-4c85-9d40-16974ea33152 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Navilyst Medical |
| Version Model Number | 95-902 |
| 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 |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Catheter Gauge | 6 French |
| Needle Gauge | 21 Gauge |
| Guidewire Length | 60 Centimeter |
| Guidewire Diameter | 0.018 Inch |
| Catheter Length | 7 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H965459020 [Primary] |
| HIBCC | H965459021 [Package] Contains: H965459020 Package: Box [5 Units] In Commercial Distribution |
| OFL | Percutaneous Sheath Introducer Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-29 |
| Device Publish Date | 2024-10-21 |
| 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 |
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 |