FDA UDI In Commercial Distribution 🇺🇸 United States

SR Ivolen

DI: DIVO5303631 · Model: 530363 · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2

Basic Information

Brand Name
SR Ivolen
Primary DI
DIVO5303631
Version / Model
530363
Catalog Number
530363
Company Name
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Labeler DUNS
448015938
Distribution Status
In Commercial Distribution
Device Count in Pkg
2
Record Status
Published
Publish Date
2020-08-26
Public Version
2
Public Version Date
2022-03-17
Public Version Status
Update
Public Device Record Key
8f44754b-d97d-4a76-9c29-4ae384418817

Device Description

SR Ivolen Powder 2x500 g

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
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
EBH MATERIAL, IMPRESSION TRAY, RESIN

GMDN Terms

Code Name
58106 Dental impression tray material

Identifiers

Type ID
Unit of Use DVIV5303630
Primary DIVO5303631