DEVICE: Symmetry Surgical (00887482094242)

Device Identifier (DI) Information

Symmetry Surgical
57-1050
In Commercial Distribution
57-1050
SYMMETRY SURGICAL INC.
00887482094242
GS1
January 01, 9999
1
079641356 *Terms of Use
Rongeur Surgical 6In 6mm Up Cut Bite Raney Kerrison Ultra Instruments
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Neurosurgical rongeur A hand-held manual surgical instrument designed with a cutting/biting action used for the removal of bone, e.g., pieces of the skull, during a neurosurgical intervention. It is a strongly constructed instrument that has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. It is available in various sizes and is made of high-grade stainless steel and designed to withstand the forces which are applied. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
HAE Rongeur, Manual
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K081651 000
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Sterilization

No
Yes
Sterilization Method [?]
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
No Device Sizes
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Device Record Status

3f7dbcf7-98d6-4ff9-a24a-6dd75e8f10ac
July 06, 2018
3
September 21, 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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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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