DEVICE: Henry Schein (00304040005798)

Device Identifier (DI) Information

Henry Schein
1010711
In Commercial Distribution
1010711
HENRY SCHEIN, INC.
00304040005798
GS1

1
012430880 *Terms of Use
Etch Gel Bulk
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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
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FDA Product Code

[?]
Product Code Product Code Name
KLE AGENT, TOOTH BONDING, RESIN
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep out of sun
Storage Environment Temperature: between 50 and 75 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 24 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Syringe Tip x 20
Weight: 12 Gram
Device Size Text, specify: Syringe
Needle Gauge: 22 Gauge
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Device Record Status

e8546a50-d91c-40af-b7a6-25bce8c50e48
March 29, 2018
2
September 24, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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