DEVICE: METZENBAUM PREPARATION SCISSORS INSERT (B09929013010)

Device Identifier (DI) Information

METZENBAUM PREPARATION SCISSORS INSERT
2901-301
Not in Commercial Distribution

SONTEC INSTRUMENTS, INC.
B09929013010
HIBCC
June 22, 2018
1
040729840 *Terms of Use
METZENBAUM PREPARATION SCISSORS STRAIGHT DOUBLE-ACTION JAWS
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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
General-purpose surgical scissors, reusable A hand-held manual surgical instrument designed cut a variety of tissues during surgery (i.e., is not dedicated to a specific anatomy/clinical intended use); it may in addition be intended for cutting sutures or other materials associated with surgery. It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed. It is typically made of high-grade stainless steel and is available in various designs and sizes; the blades may have different shapes. Some types can have carbide inserts along the cutting edges. This is a reusable device intended to be sterilized prior to use.
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FDA Product Code

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Product Code Product Code Name
GEI Electrosurgical, Cutting & Coagulation & Accessories
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K002877 000
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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

[?]
Size Type Text
Length: 360 Millimeter
Device Size Text, specify: 5mm Shaft
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Device Record Status

1dcde079-ec85-4bb3-8213-2b9d7aafdd7b
July 06, 2018
7
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

[?]
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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