FDA UDI In Commercial Distribution 🇺🇸 United States

Ivostar Gnathostar

DI: DIVO6128821 · Model: 612882 · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Ivostar Gnathostar
Primary DI
DIVO6128821
Version / Model
612882
Catalog Number
612882
Company Name
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Labeler DUNS
448015938
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-01-22
Public Version
1
Public Version Date
2019-02-22
Public Version Status
New
Public Device Record Key
eacf9e62-a211-43d3-bee5-8b9ef4f87733

Device Description

Gnathostar Set of 8 A-D LD84 BL3

Device Characteristics

Single Use
No
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
No
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
Primary DIVO6128821