FDA UDI In Commercial Distribution 🇺🇸 United States

Zirlux

DI: 00304040103968 · Model: 9012492 · HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Zirlux
Primary DI
00304040103968
Version / Model
9012492
Catalog Number
9012492
Company Name
HENRY SCHEIN, INC.
Labeler DUNS
012430880
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-12-04
Public Version
2
Public Version Date
2021-10-29
Public Version Status
Update
Public Device Record Key
cc29fec9-ec91-47c9-924b-260606287346

Device Description

ZIRLUX ACETAL MILLING DISC G2 (BLEACHED) 71 x 20 mm

Device Characteristics

Single Use
No
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
Yes
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
EHP CLASP, PREFORMED

GMDN Terms

Code Name
45236 Temporary dental crown/bridge resin

Identifiers

Type ID
Primary 00304040103968

Storage Conditions

Type
Special Storage Condition, Specify
Special Conditions
n/a
Type
Storage Environment Temperature
Temperature Range
High: 193 Degrees Celsius