DEVICE: Henry Schein (00304040005118)

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Device Record History
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Device Identifier (DI) Information
Henry Schein
1001540
In Commercial Distribution
1001540
HENRY SCHEIN, INC.
00304040005118
GS1

1
012430880 *Terms of Use
Polycarboxylate Cement Kit
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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?
16705 Zinc polycarboxylate dental cement
A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between zinc oxide (ZnO) and aqueous solutions of polycarboxylic acid (e.g., polyacrylic acid). It typically includes some additional fillers/components. After application, this device cannot be reused.
Active false
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FDA Product Code

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Product Code Product Code Name
EMA CEMENT, DENTAL
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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

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Storage and Handling
Storage Environment Temperature: between 2 and 10 Degrees Celsius
Storage Environment Temperature: between 35 and 50 Degrees Fahrenheit
Special Storage Condition, Specify: Keep out of sun
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Liquid
Device Size Text, specify: Powder
Weight: 40 Gram
Weight: 60 Gram
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Device Record Status
ae0b1722-3746-4b7f-9150-2e882d15e50a
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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