DEVICE: Maxicide 28 day (00304040003961)
Device Identifier (DI) Information
Maxicide 28 day
1026003
In Commercial Distribution
1026003
HENRY SCHEIN, INC.
1026003
In Commercial Distribution
1026003
HENRY SCHEIN, INC.
Sterilizing and Disinfecting Solution
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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No | |
No | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Glutaraldehyde device sterilant | A liquid substance that includes glutaraldehyde as its primary agent intended to completely destroy or eliminate (sterilize) all harmful microorganisms on a medical device (e.g., surgical or dental instrument); it may also be intended for use as a high-level disinfectant. The medical device is typically bathed by the substance for a specified period of time in order to achieve high-level disinfection or sterilization. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MED | Sterilant, medical devices |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: STORE AT ROOM TEMPERATURE |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 946 Milliliter |
Device Record Status
d8840db2-6c14-43f5-aeec-7745f9251c60
August 23, 2018
3
September 24, 2016
August 23, 2018
3
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 |
---|---|---|---|---|---|
10304040003968 | 16 | 00304040003961 | In Commercial Distribution | case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
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