DEVICE: NA (10705034726137)

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Device Identifier (DI) Information

NA
03.809.821
03809821
SYNTHES (U.S.A.) LP
10705034726137
GS1
1
PADDLE SHAVER 11MM HEIGHT
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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
Intervertebral disc rongeur A surgical instrument designed for introduction between the bodies of vertebrae for the removal of the broad and flattened disc of fibrocartilage through a cutting/biting action. It is typically made of high-grade stainless steel and constructed as a long instrument with one sliding and one stationary rod, each having a sharp-edged, scoop-shaped, jaw at the distal end which is activated through two pivoted handles that, when squeezed together, close the jaws to bite (cut) through tissue. It is designed to withstand the forces which are applied in order to bite over such tough tissue whilst having a thin enough profile to enable entry into this narrow space. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
HTR RASP
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
December 31, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Issuing Agency [?] Secondary DI Number
HIBCC H981038098210
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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
Yes
07611819373983
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)255-2500
xx@xx.xx
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