DEVICE: ZipFix (20887587025985)

Device Identifier (DI) Information

ZipFix
08.501.001.05S
In Commercial Distribution
0850100105S
Synthes GmbH
20887587025985
GS1

5
486711679 *Terms of Use
STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK
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Device Characteristics

MR Safe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
34017 Sternal fixation device
A collection of devices intended to be used for primary or secondary closure/repair of the sternum, typically following sternotomy or fracture of the sternum, to stabilize the sternum and promote fusion. The sternal fixation system (SFS) typically consist of titanium (Ti) or high-grade stainless steel plates, pins, cables, and locking screws, which are used to selectively create the device construct by the surgeon. This is a single-patient device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
JDQ CERCLAGE, FIXATION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K110789 000
No CLOSE

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 Record Status

d19fca86-910b-4380-afcf-738eed332b57
April 25, 2022
4
September 14, 2015
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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 H9800850100105S0
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Unit of Use DI

[?]
Unit of Use DI Number: 80887587025987 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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