DEVICE: RETRACTOR (B09928008000)

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Device Identifier (DI) Information

RETRACTOR
2800-800

SONTEC INSTRUMENTS, INC.
B09928008000
HIBCC
1
HEARTLINE RETRACTOR WITH 2 INSERTS & 2x COOLEY BLADES
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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
Rib spreader A self-locking surgical instrument designed to force apart two adjacent ribs to permit examination or intervention in the thoracic cavity. This device will typically have two interchangeable blades at the distal end that hook over the ribs to be parted, and a ratchet mechanism along its horizontal bar to adjust the blades and maintain its set position once it has been set. It is also known as a rib retractor and is available in various designs and sizes. It is typically made of high-grade stainless steel but types used for paediatrics may be made of corrosive resistant aluminium (Al). 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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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
Device Size Text, specify: 30mm DEEP 18cm SPREAD
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Device Status

In Commercial Distribution
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

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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

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