Navilyst Medical
MiniStick II Microintroducer Kit 3F, Peelable Sheath/Dilator, 45cm Nitinol/SS Guidewire
2manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
Record
| Listed by | AngioDynamics, Inc., United States |
|---|---|
| FDA product code | OFL |
| Device type | Percutaneous Sheath Introducer Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-10-21 |
| Record revised | 2025-05-02 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 5 |
| Sizes | Catheter length 5 to 60 cm; catheter gauge 3 to 6 Fr; guidewire diameter 0.018 in; needle gauge 21 G; guidewire length 45 to 60 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 45-916 | Catheter Gauge 5 Fr | In distribution |
| 45-900 | Needle Gauge 21 G | In distribution |
| 45-915 | Needle Gauge 21 G | In distribution |
| 45-917 | Catheter Gauge 6 Fr | In distribution |
| 45-902 | Catheter Gauge 6 Fr | In distribution |
| 45-918 | Catheter Gauge 3 Fr | In distribution |
| 45-901 | Catheter Gauge 5 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Micro-Introducer Kit | Galt Medical Corp. | 53 |
| Micro-Access Tearaway Introducer Kit | Galt Medical Corp. | 49 |
| Tearaway Introducer Kit | Galt Medical Corp. | 35 |
| Stiffen Micro-Introducer Kit | Galt Medical Corp. | 28 |
| Elite Transitionless Micro-Introducer Kit | Galt Medical Corp. | 24 |
| Valved Tearaway Kit | Galt Medical Corp. | 24 |
| Typenex Introducer Set | Typenex Medical, LLC | 23 |
| Transitionless Micro-Introducer Kit | Galt Medical Corp. | 20 |
| Transitionless Stiffen Micro-Introducer Kit | Galt Medical Corp. | 19 |
| Seamless™ | B. Braun Medical Inc. | 19 |
| Stradis | Stradis Healthcare | 16 |
| TVS LPA | Galt Medical Corp. | 13 |
Showing 12 of 40. All products under Percutaneous Sheath Introducer Kit
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.