FDA UDI In Commercial Distribution 🇺🇸 United States

Ivostar / Gnathostar

DI: 07615208389883 · Model: 577561 · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
Ivostar / Gnathostar
Primary DI
07615208389883
Version / Model
577561
Catalog Number
577561
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
5a8632ed-0f0a-47a0-8426-7e6bc8f9b420

Device Description

Ivostar Set of 6 A-D U02 A3

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
Primary 07615208389883
Previous DIVO5775611