DEVICE: Dermacea (10884521059757)

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Device Record History
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Device Identifier (DI) Information
Dermacea
441403
In Commercial Distribution
441403
Cardinal Health, Inc.
10884521059757
GS1
December 31, 2025
2
080935429 *Terms of Use
Non-woven Sponges,4 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?
48131 Non-woven gauze pad
A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum; in some cases, the device’s packaging may be used as a disposable tray. 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
Length: 2 Inch
Width: 2 Inch
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Device Record Status
e709d9d9-00a6-42d9-84da-90863f4443d2
November 07, 2024
5
June 27, 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
20884521059754 50 10884521059757 2025-12-31 In Commercial Distribution PACK_OR_INNER_PACK
30884521059751 3000 10884521059757 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

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Unit of Use DI Number: 40884521059758 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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