FDA UDI
In Commercial Distribution
🇺🇸 United States
StecoTitanmagnetics®
DI: ESTOI0102K1500
·
Model: I.01.02.K150
·
steco-System-Technik GmbH & Co KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- StecoTitanmagnetics®
- Primary DI
- ESTOI0102K1500
- Version / Model
- I.01.02.K150
- Catalog Number
- I.01.02.K150
- 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
- e90d28ca-a1d3-4b7f-9347-4c852a2b81ed
Device Description
Titanmagnetics® Insert K-Line D5.2/H1.5 for Straumann Implant RN Ø4.8 -> 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
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EGG | Attachment, Precision, All | Dental | 872.3165 | 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 | ESTOI0102K1500 | HIBCC |
Customer Contacts
- Phone
- +49405577810
- [email protected]