DEVICE: PROFYLE (07613154583829)

Device Identifier (DI) Information

PROFYLE
59-12049E
In Commercial Distribution
59-12049E
Stryker Trauma SA
07613154583829
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, non-sterile A non-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

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

[?]
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

eca9b016-8024-4aa5-9a4d-d4c068cd4c7d
July 06, 2018
3
June 24, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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