FDA UDI In Commercial Distribution 🇺🇸 United States

Magnabutments

DI: 05060483010694 · Model: IT-MA2-S Maxi Magnabutment (Southern Implants) – S-Range · TECHNOVENT LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Magnabutments
Primary DI
05060483010694
Version / Model
IT-MA2-S Maxi Magnabutment (Southern Implants) – S-Range
Catalog Number
IT-MA2-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
c7efcf7e-e58a-4072-a0ae-9cd57183e054

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
DZE Implant, Endosseous, Root-Form

GMDN Terms

Code Name
38578 Magnetic dental precision attachment

Identifiers

Type ID
Primary 05060483010694

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.