DEVICE: MetriZyme (00615375005729)

Device Identifier (DI) Information

MetriZyme
10-4050
In Commercial Distribution

METREX RESEARCH, LLC
00615375005729
GS1

1
145963778 *Terms of Use
Dual Enzymatic Detergent
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Medical device decontamination agent A non-sterile substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental, and/or surgical instruments/devices as part of the pre-cleaning and/or cleaning process to remove blood proteins and other organic compounds (decontamination) prior to disinfection or sterilization. It includes a detergent and may be added, as manufacturer specified, to water for cleaning procedures and/or be applied directly to soiled devices immediately after use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) intended to help facilitate cleaning. After application, this device cannot be reused.
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FDA Product Code

[?]
Product Code Product Code Name
MNL ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a cool area
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 5 Gallon
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Device Record Status

3d66f87c-ce4d-4f3c-b057-ced7dff56bbd
March 29, 2018
2
August 31, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
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

[?]
+18008411428
customercare@kavokerrgroup.com
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