FDA UDI
In Commercial Distribution
🇺🇸 United States
StecoTitanmagnetics®
DI: ESTOH1101X10
·
Model: H.11.01.X1
·
steco-System-Technik GmbH & Co KG
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- StecoTitanmagnetics®
- Primary DI
- ESTOH1101X10
- Version / Model
- H.11.01.X1
- Catalog Number
- H.11.01.X1
- 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
- 2018-02-12
- Public Version
- 4
- Public Version Date
- 2023-02-09
- Public Version Status
- Update
- Public Device Record Key
- 5ac123f6-fff0-4e15-8162-abbdd3e30ce4
Device Description
Titanmagnetics® torque wrench insert X-Line for Epitec-ratchet-> For further information visit steco.de
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
| 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 | ESTOH1101X10 | HIBCC |
Customer Contacts
- Phone
- +49405577810
- [email protected]