DEVICE: ProDisc-C (10705034763828)

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Device Identifier (DI) Information

ProDisc-C
09.820.056S
09820056S
SYNTHES (U.S.A.) LP
10705034763828
GS1
1
PRODISC-C IMPLANT LARGE DEEP 6MM-STERILE
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Device Characteristics

MR Conditional
No
No
Yes
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
Cervical total disc replacement prosthesis, sterile A sterile implantable device designed to replace most or all of a dysfunctional intervertebral disc in the cervical spine. It is typically made of metal or synthetic materials, or a combination of the two. It most commonly has a two-plate design, one plate attaching to the vertebra above and the other to the vertebra below. The device is intended to facilitate motion usually through the sliding action of its smooth surfaces.
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FDA Product Code

[?]
Product Code Product Code Name
MJO PROSTHESIS, INTERVERTEBRAL DISC
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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
September 08, 2014

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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 H98109820056S05
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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
Yes
No
No CLOSE

Customer Contact

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