DEVICE: SURGISTAIN (5 Liter FB38) (00810929019416)

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Device Record History
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Device Identifier (DI) Information
SURGISTAIN (5 Liter FB38)
34572-61
In Commercial Distribution

Ruhof Corporation
00810929019416
GS1

1
082779828 *Terms of Use
Enzymatic detergents used to clean medical instruments.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
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?
58062 Instrument anti-oxidation agent
A liquid substance intended to prevent corrosion on the surface of stainless steel medical/surgical instruments (e.g., specula, forceps) through its anti-oxidation properties. It is typically a concentrated phosphoric acid (H3PO4) that is used as specified by the manufacturer in an aqueous solution to treat devices by manual soaking or in an ultrasonic water bath. Also known as an instrument renovating agent, it is intended to remove protein stains, iron oxide deposits, and other oxide stains to prevent rust pitting and help improve instrument longevity. After application, this device cannot be reused.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FLG Cleaner, Ultrasonic, Medical Instrument
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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
Handling Environment Temperature: between 40 and 130 Degrees Fahrenheit
Storage Environment Temperature: between 40 and 130 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
aafcbabf-060b-4ec1-8942-86767155064e
July 08, 2025
1
June 30, 2025
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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
00810929019423 4 00810929019416 In Commercial Distribution CASE
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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

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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