StecoTitanmagnetics®
Titanmagnetics® epitheses magnet Z-Line D5.8/H3.15 universal with collar and retention ring f. silicone -> For further information visit steco.de
2manufacturers in China registered for this device type
55catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Nanning Sixtant Biotechnology Co., Ltd. | Nanning | Guangxi | Manufacturer | 13 |
Record
| Listed by | Steco-System-Technik Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | KCZ |
| Device type | Prosthesis, Breast, External, Used With Adhesive |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3800 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-03-26 |
| Record revised | 2023-02-09 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I.02.01.Z700 | In distribution | |
| U.00.02.K500 | In distribution | |
| V.00.07.W265 | In distribution | |
| I.34.01.Z450 | In distribution | |
| I.34.01.K250 | In distribution | |
| I.02.01.X800 | In distribution | |
| I.02.01.T520 | In distribution | |
| H.00.04.X3 | In distribution | |
| I.34.01.X800 | In distribution | |
| A.00.02.X695 | In distribution | |
| H.00.04.K2 | In distribution | |
| V.00.06.W265 | In distribution | |
| I.34.02.X260 | In distribution | |
| V.00.08.W265 | In distribution | |
| I.02.01.Z800 | In distribution | |
| A.00.02.T750 | In distribution | |
| I.34.01.K450 | In distribution | |
| V.00.01.X250 | In distribution | |
| U.00.01.K500 | In distribution | |
| I.02.07.X370 | In distribution | |
| U.00.01.T570 | In distribution | |
| I.34.01.X600 | In distribution | |
| I.02.01.X350 | In distribution | |
| I.11.01.X300 | In distribution | |
| U.00.01.Z315K | In distribution | |
| H.00.04.K4 | In distribution | |
| M.00.01.T1050 | In distribution | |
| I.34.01.T400 | In distribution | |
| H.00.04.X2 | In distribution | |
| V.00.02.X250 | In distribution | |
| U.00.02.T570 | In distribution | |
| V.00.01.Z300 | In distribution | |
| U.00.01.X265K | In distribution | |
| I.34.02.Z330 | In distribution | |
| H.00.04.T2 | In distribution | |
| H.00.04.T3 | In distribution | |
| I.02.06.X520 | In distribution | |
| V.00.03.X260 | In distribution | |
| H.00.04.K3 | In distribution | |
| H.00.04.T4 | In distribution | |
| A.00.01.X555 | In distribution | |
| I.02.01.T720 | In distribution | |
| I.11.01.Z380 | In distribution | |
| I.34.02.T300 | In distribution | |
| I.34.02.K200 | In distribution | |
| I.02.01.K450 | In distribution | |
| U.00.02.X265 | In distribution | |
| I.02.01.X500 | In distribution | |
| U.00.02.Z315 | In distribution | |
| I.34.01.X450 | In distribution | |
| H.00.04.T1 | In distribution | |
| I.34.01.X260 | In distribution | |
| U.00.02.Z315K | In distribution | |
| U.00.02.X265K | In distribution | |
| H.00.04.Z1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Amoena | Amoena Medizin-Orthopädie-Technik GmbH | 230 |
| my breast | Natural Breast K.K. | 37 |
| Straumann Extraoral Implant System | Institut Straumann AG | 13 |
| Massage Form® Attach | American Breast Care, L.P. | 12 |
| ABC Nipple | American Breast Care, L.P. | 9 |
| Massage Form® Shaper Attach | American Breast Care, L.P. | 9 |
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.