DEVICE: Henry Schein (00304040004005)

Device Identifier (DI) Information

Henry Schein
1007001
In Commercial Distribution
1007001
HENRY SCHEIN, INC.
00304040004005
GS1

1
012430880 *Terms of Use
Tray Adhesive
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Alginate dental impression material A material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
ELW MATERIAL, IMPRESSION
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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
Special Storage Condition, Specify: Keep out of sun
Storage Environment Temperature: between 17 and 26 Degrees Celsius
Storage Environment Temperature: between 63 and 79 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
Total Volume: 1 Fluid Ounce
Device Size Text, specify: Bottle
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Device Record Status

1ff9b9ef-01e1-4a70-8bfe-caa19d972d88
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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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