FDA UDI
In Commercial Distribution
🇺🇸 United States
‘MagnaCap’ Magnetic Retention System
DI: 05060483010878
·
Model: Magnacap Mini Latch Capfit Tool
·
TECHNOVENT LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ‘MagnaCap’ Magnetic Retention System
- Primary DI
- 05060483010878
- Version / Model
- Magnacap Mini Latch Capfit Tool
- Catalog Number
- CF3
- Company Name
- TECHNOVENT LIMITED
- Labeler DUNS
- 225835156
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-22
- Public Version
- 1
- Public Version Date
- 2024-07-30
- Public Version Status
- New
- Public Device Record Key
- a4482caf-1cbb-443c-b825-2c5f7d281d20
Device Description
The Technovent Magnacap System is a magnetic attachment system for implant retained craniofacial and dental 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
- No
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 | 05060483010878 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- The components of the Magnacap System are supplied non-sterile and individually packaged for single patient use. It is recommended that they be stored and transported in their original packaging.
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store out of direct sunlight. Do not use if the packaging is open or has been damaged and do not use after the labelled expiry date.