DEVICE: PROFYLE (07613154754991)

Device Identifier (DI) Information

PROFYLE
59-12049S
In Commercial Distribution
59-12049S
Stryker Trauma SA
07613154754991
GS1

1
481999654 *Terms of Use
WASHER FOR 1.2MM BONE SCREWS
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Device Characteristics

Labeling does not contain MRI Safety Information
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
Orthopaedic bone washer, sterile A sterile flat thin ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
HRS PLATE, FIXATION, BONE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K062498 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
Device Size Text, specify: Diameter: 2.2 Millimeter
Device Size Text, specify: Thickness: 0.55 Millimeter
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Device Record Status

1f209112-39d5-4630-afce-57585256c18a
July 06, 2018
3
July 01, 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

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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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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