DEVICE: NERVE HOOK (B099280074870)

Device Identifier (DI) Information

NERVE HOOK
2800-7487
In Commercial Distribution

SONTEC INSTRUMENTS, INC.
B099280074870
HIBCC

1
040729840 *Terms of Use
HEARTLINE NERVE HOOK
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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
Nerve/vessel retractor A hand-held, non-self-retaining surgical instrument intended to be used for hooking around a nerve, tendon, or blood vessel to separate it from the surrounding tissue during a surgical intervention. It is a shaft-like instrument with a blunt bulbous or rounded retraction tip (a hook) at the distal end and a handle at the proximal end. It is available in a variety of designs such as, curved, right-angled, or 45 degree angled. It is made of high-grade stainless steel. 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: 16.75 Inch
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Device Record Status

8dcea4f8-5566-4d70-910b-b93b0e793828
March 29, 2018
2
October 14, 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

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Yes
No
No
No
No CLOSE

Customer Contact

[?]
800-821-7496
info@sontecinstruments.com
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