Seamless™
4F MIK 7CM NDL-018 NT GW W/A TIP-Stif
2manufacturers in China registered for this device type
19catalogue 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 | B. Braun Medical 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-07-02 |
| Record revised | 2022-06-10 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 655418 | Gauge (cannula) : 21 | 10 | In distribution |
| 655410 | Gauge (cannula) : 21 | 10 | In distribution |
| 655409 | Gauge (cannula) : 21 | 10 | In distribution |
| 655401 | 10 | In distribution | |
| 655400 | 10 | In distribution | |
| 655404 | 10 | In distribution | |
| 655416 | Gauge (cannula) : 21 | 10 | In distribution |
| 655403 | Gauge (cannula) : 21 | 10 | In distribution |
| 655417 | Gauge (cannula) : 21 | 10 | In distribution |
| 655402 | Gauge (cannula) : 21 | 10 | In distribution |
| 655406 | 10 | In distribution | |
| 655411 | 10 | In distribution | |
| 655414 | 10 | In distribution | |
| 655412 | 10 | In distribution | |
| 655415 | 10 | In distribution | |
| 655405 | 10 | In distribution | |
| 655413 | 10 | In distribution | |
| 655407 | 10 | In distribution | |
| 655408 | Gauge (cannula) : 21 | 10 | 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 |
| 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.