Kolenda
Kolenda Salivary Access Introducer Set
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (2), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | OAJ |
| Device type | Catheter, Drainage, Intraoral/Extraoral |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-10-02 |
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, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G24132 | In distribution | |
| G24129 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rabinov | Cook Incorporated | 8 |
| Manashil | Cook Incorporated | 4 |
| Yune-Klatte | Cook Incorporated | 2 |
| Sialocath Salivary Duct Catheter | C2Dx, Inc. | 1 |
| SialoCath | Cook Incorporated | 1 |
| Kolenda Salivary Introducer Set – 6.0 | C2Dx, Inc. | 1 |
| Kolenda Salivary Introducer Set – 5.0 | C2Dx, Inc. | 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.