DEVICE: Dukal (10665973018024)

Device Identifier (DI) Information

Dukal
7215327 and 7270033 and 7515327
In Commercial Distribution
7215327 and 7270033 and 7515327
Dukal LLC
10665973018024
GS1

1
791014871 *Terms of Use
Non-Woven Pad 3" x 3" 4-Ply, Sterile
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

6ffb792d-69e1-4589-bff8-717904d4ae1d
April 23, 2025
4
December 02, 2022
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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
60665973018029 100 10665973018024 2025-04-22 Not in Commercial Distribution box
50665973018022 36 40665973018025 In Commercial Distribution Case
40665973018025 25 10665973018024 In Commercial Distribution box
20665973018021 10 10665973018024 In Commercial Distribution Box
30665973018028 36 20665973018021 In Commercial Distribution Case
70665973018026 12 60665973018029 2025-04-22 Not in Commercial Distribution Case
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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
No
No CLOSE

Customer Contact

[?]
+1(631)656-3800 172
kmckigney@dukal.com
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