DEVICE: MICASEPT TOP DUR NEEDLE HOLDER (B09920918070000)

Device Identifier (DI) Information

MICASEPT TOP DUR NEEDLE HOLDER
20918-07-000
In Commercial Distribution

SONTEC INSTRUMENTS, INC.
B09920918070000
HIBCC
September 23, 2018
1
040729840 *Terms of Use
MICASEPT TOP DUR DIRONDAL NEEDLE HOLDER STRAIGHT WITH HEGAR RATCHET SHORT WIDE JAW
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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
Needle holder, reusable A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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
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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: 6MM Diameter
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Device Record Status

bf5dedc7-ed66-498d-b1fb-15015ed8b463
August 24, 2018
6
September 22, 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

[?]
8008217496
INFO@SONTECINSTRUMENTS.COM
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