DEVICE: KINCISE™ (00845384018629)

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Device Record History
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Device Identifier (DI) Information
KINCISE™
1013-00-901
In Commercial Distribution
1013-00-901
Synthes GmbH
00845384018629
GS1

1
486711679 *Terms of Use
KINCISE FEM HEAD IMPACTOR, REPLACE CAP
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
47845 Surgical power tool adaptor
A connecting device designed as a mechanical coupling to join and lock together a distal tool to the surgical power tool to provide the power when these are incompatible and are of a different manufacture/industry standard. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and sizes. This device may be cannulated to allow the use of a guidewire. There are various types such as a Hudson adaptor, Trinkle adaptor, Zimmer adaptor. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GEY MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

[?]
Storage and Handling
Handling Environment Temperature: between -29 and 60 Degrees Celsius
Handling Environment Atmospheric Pressure: between 59.5 and 106 KiloPascal
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
70177b54-eeb3-4249-80a1-444ccbba89a0
July 29, 2024
4
April 28, 2020
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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
No Secondary DIs found
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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
No
No
No CLOSE

Customer Contact

[?]
+1(800)255-2500
RA-DPYNA-ANSPACHPOWE@ITS.JNJ.COM
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