Lingeman Percutaneous Tract Kit
Percutaneous Tract Kit
1manufacturer
1catalogue number
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | OFC |
| Device type | Catheter Introducer Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2024-10-11 (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 | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2023-09-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M0064501150 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 16 |
| Prytime Medical Devices, Inc. | Prytime Medical Devices, Inc. | 2 |
| TorqMax Sheath Grip Accessory | Spectranetics Corp. | 1 |
| Percutaneous Tract Kit | Boston Scientific Corporation | 1 |
| Landmark Catheter Introducer Kit | Zien Medical Technologies LLC | 1 |
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.