DEVICE: Henry Schein (00304040007051)
Device Identifier (DI) Information
Henry Schein
9001472
In Commercial Distribution
9001472
HENRY SCHEIN, INC.
9001472
In Commercial Distribution
9001472
HENRY SCHEIN, INC.
Caries Indicator Syringe Kit
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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60408 | Dental caries detecting stain |
A liquid substance intended for use in dentistry as a staining agent to detect early stage dental caries and/or to monitor the progress of caries. It typically consists of two solutions (e.g., metal fluorides) that are applied separately to the suspect area of the tooth/teeth, and change colour in the presence of the caries-producing bacteria or bacterial residues, and/or remnants of the tooth structure from a carious lesion. The staining produced can be monitored over time to assess the progression/remission of the caries. After application, this device cannot be reused.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LFC | DEVICE, CARIES DETECTION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 10 and 24 Degrees Celsius |
Storage Environment Temperature: between 50 and 75 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Syringe |
Total Volume: 1 Milliliter |
Needle Gauge: 22 Gauge |
Device Size Text, specify: Syringe Tip x 20 |
Device Record Status
0a3d05de-dd54-4ca7-aa74-52972b83c31c
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 |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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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