DEVICE: Zirlux (00304040110997)
Device Identifier (DI) Information
Zirlux
9012495
In Commercial Distribution
9012495
HENRY SCHEIN, INC.
9012495
In Commercial Distribution
9012495
HENRY SCHEIN, INC.
Zirlux Acetal LTD A3.5 98x22MM
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
45236 | Temporary dental crown/bridge resin |
A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EHP | CLASP, PREFORMED |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: n/a |
Storage Environment Temperature: less than 193 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Height: 22 Millimeter |
Device Record Status
52009bd1-08aa-40aa-8d60-544b80be0cef
October 29, 2021
2
July 18, 2019
October 29, 2021
2
July 18, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined