DEVICE: TITANIUM MICTEC FLEXIBLE TROCAR SET (B09920913170)

Device Identifier (DI) Information

TITANIUM MICTEC FLEXIBLE TROCAR SET
20913-17
In Commercial Distribution

SONTEC INSTRUMENTS, INC.
B09920913170
HIBCC
September 22, 2018
1
040729840 *Terms of Use
TITANIUM MICTEC FLEXIBLE TROCAR SET
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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
Laparoscopic surgical procedure kit, non-medicated, reusable A collection of various laparoscopic and surgical instruments (e.g., access cannulae, irrigation/aspiration cannula, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a reusable device.
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K002877 000
No 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

[?]
Size Type Text
Length: 70 Millimeter
Device Size Text, specify: 13mm DIameter
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Device Record Status

fcf07055-a2cf-403b-89bb-0e57be85fd3e
August 24, 2018
4
September 23, 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
No
No
No CLOSE

Customer Contact

[?]
8008217496
INFO@SONTECINSTRUMENTS.COM
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