FDA UDI In Commercial Distribution 🇺🇸 United States

Zirlux

DI: 00304040132890 · Model: 9012584 · HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Zirlux
Primary DI
00304040132890
Version / Model
9012584
Catalog Number
9012584
Company Name
HENRY SCHEIN, INC.
Labeler DUNS
012430880
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-07-20
Public Version
2
Public Version Date
2020-11-02
Public Version Status
Update
Public Device Record Key
f714a5dd-46ee-4350-9db8-d6a100e333b0

Device Description

Zirlux TR OM2 98x14mm

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EIH POWDER, PORCELAIN

GMDN Terms

Code Name
16187 Dental appliance fabrication material, ceramic

Identifiers

Type ID
Primary 00304040132890