DEVICE: MICTEC SUCTION-IRRIGATION TUBE (B0990411012040)

Device Identifier (DI) Information

MICTEC SUCTION-IRRIGATION TUBE
04-11012-04
In Commercial Distribution

SONTEC INSTRUMENTS, INC.
B0990411012040
HIBCC

1
040729840 *Terms of Use
MICTEC SUCTION-IRRIGATION TUBE ROTABLE CURVED
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Suction cannula, reusable A rigid or semi-rigid, hand-held, metal or durable plastic tube designed as a conduit for the evacuation (suctioning) of blood, fluids, and other tissue debris directly from the surgical site during a surgical procedure (e.g., open-, plastic-, tissue/bone morcellation surgery). Also known as a suction tube, it is typically a general-purpose device to which the suction system tubing is connected proximally; some types may be attached to a dedicated handpiece that typically have a valve. Dedicated cannula specifically intended for a particular procedure (e.g., bronchial, dental, eye, uterine, oral, and liposuction) are also available. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
GCJ Laparoscope, General & Plastic Surgery
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FDA Premarket Submission

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

No
Yes
Sterilization Method [?]
Dry Heat Sterilization
Moist Heat or Steam 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: 300 Millimeter
Device Size Text, specify: 5mm Tip
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Device Record Status

1092ec07-1f4e-4de9-81c6-ecb9ef62120a
April 06, 2018
3
September 23, 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

[?]
8008217496
INFO@SONTECINSTRUMENTS.COM
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