FDA UDI In Commercial Distribution 🇺🇸 United States

‘MagnaCap’ Magnetic Retention System

DI: 05060483010953 · Model: Magnacap Mini Locator Ring · TECHNOVENT LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
‘MagnaCap’ Magnetic Retention System
Primary DI
05060483010953
Version / Model
Magnacap Mini Locator Ring
Catalog Number
LR1
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
26b925ac-bc73-436f-9631-d65f8b59c375

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
EGG Attachment, Precision, All

GMDN Terms

Code Name
38578 Magnetic dental precision attachment

Identifiers

Type ID
Primary 05060483010953

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.