FDA UDI
In Commercial Distribution
🇺🇸 United States
StecoTitanmagnetics®
DI: ESTOU0002K5000
·
Model: U.00.02.K500
·
steco-System-Technik GmbH & Co KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- StecoTitanmagnetics®
- Primary DI
- ESTOU0002K5000
- Version / Model
- U.00.02.K500
- Catalog Number
- U.00.02.K500
- Company Name
- steco-System-Technik GmbH & Co KG
- Labeler DUNS
- 389566209
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-24
- Public Version
- 1
- Public Version Date
- 2023-08-01
- Public Version Status
- New
- Public Device Record Key
- 4595766a-baa5-4ec9-9611-a86f48fd5887
Device Description
Titanmagnetics® prostheses magnet K-Line D5.2/H5.0 universal with retention ring for silicone -> For further information visit steco.de
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KCZ | Prosthesis, Breast, External, Used With Adhesive | General, Plastic Surgery | 878.3800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38578 | Magnetic dental precision attachment | A device with magnetic properties designed for fixation of a removable dental prosthesis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | ESTOU0002K5000 | HIBCC |
Customer Contacts
- Phone
- +49405577810
- [email protected]