DEVICE: HOUSE SUCTION-IRRIGATOR (B099412715C0)

Device Identifier (DI) Information

HOUSE SUCTION-IRRIGATOR
412-715C
In Commercial Distribution

SONTEC INSTRUMENTS, INC.
B099412715C0
HIBCC

1
040729840 *Terms of Use
HOUSE SUCTION-IRRIGATOR
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
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
Surgical irrigation/aspiration tip, fibreoptic-illuminated A device that is attached to a suction system via the distal end of a suction tube or a handpiece (a handle) with one or two lumens and connected to a suction system controller, an irrigator, and a light source, and is used to clean and improve visualization of a clinical or surgical procedure site (e.g., body cavities) when excellent illumination is needed. It has a built-in fibreoptic bundle used to conduct the light to enhance visualization of the operative site. It is typically made of plastic and metal materials. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
JOL Catheter And Tip, Suction
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FDA Premarket Submission

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

Sterilization

No
Yes
Sterilization Method [?]
Dry Heat Sterilization
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Length: 4.5 Inch
Device Size Text, specify: 4x5 French Inner Diameter
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Device Record Status

269d54d7-8e5d-4028-b578-8a422f1e464e
April 04, 2018
3
August 19, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
800-821-7496
info@sontecinstruments.com
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