DEVICE: KURTZ CUTOFF SUCTION ADAPTER (B099412738550)

Device Identifier (DI) Information

KURTZ CUTOFF SUCTION ADAPTER
412-738-55
Not in Commercial Distribution

SONTEC INSTRUMENTS, INC.
B099412738550
HIBCC
September 21, 2018
1
040729840 *Terms of Use
KURTZ CUTOFF SUCTION ADAPTER
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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 power tool adaptor A connecting device designed as a mechanical coupling to join and lock together a distal tool to the surgical power tool to provide the power when these are incompatible and are of a different manufacture/industry standard. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and sizes. This device may be cannulated to allow the use of a guidewire. There are various types such as a Hudson adaptor, Trinkle adaptor, Zimmer adaptor. 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 [?]
Moist Heat or Steam Sterilization
Dry Heat Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Length: 2.2 Inch
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Device Record Status

6b258931-bc66-4699-a5c7-847ecb2b18ca
September 21, 2018
6
August 19, 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

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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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