DEVICE: Devon (30884527015911)

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Device Record History
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Device Identifier (DI) Information
Devon
31145751
In Commercial Distribution
31145751
Cardinal Health, Inc.
30884527015911
GS1
December 31, 2025
9
080935429 *Terms of Use
Utility Marker Labels
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
Yes
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?
61575 Skin marking pen, single-use
A dedicated pen intended to be used to delineate areas on the skin surface of a patient (e.g., to outline surgical incision sites, for dermatology applications) utilizing non-toxic ink. It is typically a felt-tip pen which may include a sterile disposable ruler. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FZZ MARKER, SKIN
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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
Special Storage Condition, Specify: ;
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
18cdec62-0800-4a00-a582-d0f1062912f5
October 09, 2024
3
June 29, 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
10884527015917 900 30884527015911 2025-12-31 In Commercial Distribution CASE
20884527015914 225 30884527015911 2025-12-31 In Commercial Distribution PACK_OR_INNER_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: 40884527015918 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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