Catheter
EAR, Hartmann, NO. 3
2manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Tianjin (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tianjin Tairuibosi Medical Appliance Co., Ltd. | Tianjin | Tianjin | Private-label distributor | 30 |
| Shenzhen Alex Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
Record
| Listed by | KLS-Martin L.P., United States |
|---|---|
| FDA product code | GBY |
| Device type | Catheter, Eustachian, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-26 |
| Record revised | 2025-01-27 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2025-01-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 36-321-03-01 | 15 CM | Withdrawn |
| 36-321-01-01 | 15 CM | Withdrawn |
| 36-321-02-01 | 15 CM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aesculap | Aesculap AG | 4 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 2 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 2 |
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.