FDA UDI In Commercial Distribution 🇺🇸 United States

ProBase Hot / ProBase Cold

DI: 07615208006148 · Model: 531542 · IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4

Basic Information

Brand Name
ProBase Hot / ProBase Cold
Primary DI
07615208006148
Version / Model
531542
Catalog Number
531542
Company Name
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Labeler DUNS
448015938
Distribution Status
In Commercial Distribution
Device Count in Pkg
4
Record Status
Published
Publish Date
2023-08-15
Public Version
1
Public Version Date
2023-08-23
Public Version Status
New
Public Device Record Key
9f5dec01-16b4-4bc3-bdc5-9ca4636eba62

Device Description

ProBase Cold Monomer 4x1000 ml

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
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EBI RESIN, DENTURE, RELINING, REPAIRING, REBASING

GMDN Terms

Code Name
16730 Dental appliance fabrication material, resin

Identifiers

Type ID
Unit of Use 07615208433272
Primary 07615208006148