Typenex Introducer Set
6F x 10cm Venous Coaxial Introducer, tipped for .018 Micro Access, .018 x 40cm NiTi/AU Mandrel Guidewire 7.0 coil with St. Tip, 21Ga x 7cm Introducer Needle - Echogenic
2manufacturers in China registered for this device type
23catalogue 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 | Typenex Medical, LLC, United States |
|---|---|
| FDA product code | OFL |
| Device type | Percutaneous Sheath Introducer Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-09-18 |
| Record revised | 2024-03-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Carton of 10, case of 10, carton of 5, pack of 10, case of 5, shipper of 10 |
| Sizes | Outer diameter 1.33 to 2.33 mm; catheter length 7 to 60 cm; length 10 to 70 cm; catheter inner diameter 1.33 to 2.33 mm |
| Distribution end date | 2024-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MS0444 | Length 45 cm | In distribution |
| MS1235S | Catheter Length 30 cm | In distribution |
| MS1512 | Catheter Length 12 cm | In distribution |
| MS1712 | Catheter Length 12 cm | In distribution |
| MS0336 | Length 24 cm | In distribution |
| MS0236 | Length 12 cm | In distribution |
| MS1344S | Length 40 cm | In distribution |
| MS0536 | Length 70 cm | In distribution |
| MS1912 | Catheter Length 10 cm | In distribution |
| MS2112 | Catheter Length 10 cm | In distribution |
| MS1612 | Catheter Length 12 cm | In distribution |
| MS2212 | Catheter Length 7 cm | In distribution |
| MS0344 | Length 24 cm | In distribution |
| MS1144S | Length 15 cm | In distribution |
| MS1335S | Catheter Inner Diameter 1.33 mm | In distribution |
| MS2012 | Catheter Length 7 cm | In distribution |
| MS0636 | Length 10 cm | In distribution |
| MS1835S | Catheter Inner Diameter 1.33 mm | In distribution |
| MS0436 | Length 45 cm | In distribution |
| MS0244 | Length 12 cm | In distribution |
| MS1244S | Length 30 cm | In distribution |
| MS2335S | Catheter Length 20 cm | In distribution |
| MS0103 | Catheter Inner Diameter 1.33 mm | Withdrawn |
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 |
| 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 |
| GaltStick Introducer Kit | 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.