FDA UDI In Commercial Distribution 🇺🇸 United States

Ivostar / Gnathostar

DI: 07615208369458 · Model: 612793 · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Ivostar / Gnathostar
Primary DI
07615208369458
Version / Model
612793
Catalog Number
612793
Company Name
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Labeler DUNS
448015938
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-02-24
Public Version
1
Public Version Date
2023-03-06
Public Version Status
New
Public Device Record Key
17e61de1-40e7-438b-83f2-c8ea82499b02

Device Description

Ivostar Set of 6 A-D U43 BL1

Device Characteristics

Single Use
Yes
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
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
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
No

Product Codes

Code Name
ELM Denture, plastic, teeth

GMDN Terms

Code Name
38643 Resin artificial teeth

Identifiers

Type ID
Previous DIVO6127931
Primary 07615208369458