DEVICE: Henry Schein (00304040005774)
Device Identifier (DI) Information
Henry Schein
1004649
In Commercial Distribution
1004649
HENRY SCHEIN, INC.
1004649
In Commercial Distribution
1004649
HENRY SCHEIN, INC.
Etch Gel Syringe Kit 40%
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
36153 | Dental etching solution |
An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KLE | AGENT, TOOTH BONDING, RESIN |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 50 and 75 Degrees Fahrenheit |
Storage Environment Temperature: between 10 and 24 Degrees Celsius |
Special Storage Condition, Specify: Keep out of sun |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Syringe x 4 |
Needle Gauge: 22 Gauge |
Device Size Text, specify: Syringe Tip x 20 |
Total Volume: 1.2 Milliliter |
Device Record Status
d8ac553e-bd1f-48bb-89e4-927b71a4ac21
March 29, 2018
2
September 24, 2016
March 29, 2018
2
September 24, 2016
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