DEVICE: Howmedica, Mix-Kit (04546540257802)

Device Identifier (DI) Information

Howmedica, Mix-Kit
6201003410
In Commercial Distribution
6201003410
STRYKER CORPORATION
04546540257802
GS1

1
196548481 *Terms of Use
I Disposable Mixing Bowl and Spatula
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Device Characteristics

Labeling does not contain MRI Safety Information
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?
33191 Manual orthopaedic cement mixer, reusable
A hand-operated manual device designed to mix polymethylmethacrylate (PMMA) powder with methylmethacrylate monomer in order to produce polymerizing bone cement. It typically includes a single-use inner mixing bowl where the cement is mixed, an outer housing with a handcrank and driving gears connected to a disposable mixing blade(s), and a lid. The device is intended to be connected to, or placed under, a fume extraction device to prevent fumes from polluting the working environment; it is typically operated outside of the sterile surgical field. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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

605e827c-02d5-4ac7-b9a0-aab2a211752a
October 25, 2018
1
September 24, 2018
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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
34546540257803 10 04546540257802 In Commercial Distribution pack
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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
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)253-3210
Inst.Stryker.cs@Stryker.com
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