DEVICE: Dermacea (10884521059672)

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Device Record History
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Device Identifier (DI) Information
Dermacea
441103
In Commercial Distribution
441103
Cardinal Health, Inc.
10884521059672
GS1
December 31, 2025
1
080935429 *Terms of Use
Gauze Fluff Roll,6 Ply
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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?
63661 Non-woven gauze roll/sheet
A device in the form of a long length of stretchable, non-woven material (e.g., rayon/polyester), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NAB Gauze / sponge,nonresorbable for external use
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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: This side up;
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Clinically Relevant Size

[?]
Size Type Text
Width: 4.50 Inch
Device Size Text, specify: Length,4.125,yard;
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Device Record Status
7f29ca82-d206-4499-86a9-4d0507a22e72
June 13, 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
20884521059679 60 10884521059672 2025-12-31 In Commercial Distribution CASE
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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
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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