DEVICE: Henry Schein (00304040005194)
Device Identifier (DI) Information
Henry Schein
1126977
In Commercial Distribution
1126977
HENRY SCHEIN, INC.
1126977
In Commercial Distribution
1126977
HENRY SCHEIN, INC.
Maxicide OPA 28 Test Strips
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
46945 | Ortho-phthalaldehyde (OPA) device disinfectant test strip |
A sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of ortho-phthalaldehyde (OPA) in a device disinfectant solution after preparation to ensure disinfectant properties. It is used to prevent diluting the disinfectant to a concentration that is lower than the manufacturer's recommended minimum effective concentration (MEC). This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JOJ | Indicator, physical/chemical sterilization process |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
8720a45f-df25-4b3e-be08-9a56c5610c68
October 16, 2023
4
September 09, 2016
October 16, 2023
4
September 09, 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 |
---|---|---|---|---|---|
20304040005198 | 2 | 00304040005194 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
10304040005191
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined