FDA UDI
In Commercial Distribution
🇺🇸 United States
Magnabutments
DI: 05060483010656
·
Model: P-MA2-6.5-S Maxi Magnabutment (Medicon, 6.5mm) – S-Range
·
TECHNOVENT LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Magnabutments
- Primary DI
- 05060483010656
- Version / Model
- P-MA2-6.5-S Maxi Magnabutment (Medicon, 6.5mm) – S-Range
- Catalog Number
- P-MA2-6.5-S
- Company Name
- TECHNOVENT LIMITED
- Labeler DUNS
- 225835156
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-14
- Public Version
- 1
- Public Version Date
- 2024-10-22
- Public Version Status
- New
- Public Device Record Key
- 665bee50-27b7-4f8d-adcc-25039c36380a
Device Description
Technovent Magnabutments are a form of magnetisable keeper which screw directly into a third party implant as part of a magnetic attachment system for implant retained craniofacial prostheses.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | Dental | 872.3640 | 2 |
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 | 05060483010656 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- The Magnabutments are supplied non-sterile and individually packaged for single patient use.
- Type
- Special Storage Condition, Specify
- Special Conditions
- It is recommended that they be stored and transported in their original packaging, at ambient temperature (between 15 and 30 degrees Celsius) and out of direct sunlight.