DEVICE: BIXCUT (04546540145857)

Device Identifier (DI) Information

BIXCUT
0227-6105
In Commercial Distribution
0227-6105
Stryker Trauma GmbH
04546540145857
GS1

1
330211587 *Terms of Use
IM Reamer, mod. Trinkle Fitting
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
11332 Cannulated surgical drill bit, reusable
A shaft of metal intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) to clear a channel of the same dimension as the diameter of the shaft. This drill is cannulated, having a hollow centre, and is typically flexible so that it can be fed over a guiding pin that has been placed into the correct position prior to operation. This device is typically used in orthopaedic surgery for clearing of the intramedullary channel prior to the insertion of a prosthetic device. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MAY Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K123604 000
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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

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Size Type Text
Length: 480.0 Millimeter
Device Size Text, specify: Diameter: 10.5 Millimeter
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Device Record Status

318c1a79-36f1-4577-820c-b2b2f5b93538
November 22, 2018
4
September 24, 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

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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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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