DEVICE: Kendall (10884521021921)

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Device Record History
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Device Identifier (DI) Information
Kendall
9256
Not in Commercial Distribution
9256
Cardinal Health, Inc.
10884521021921
GS1
April 15, 2023
1
080935429 *Terms of Use
Hydrogel Impregnated Gauze,USP Type VII Gauze Pad 1.0 oz (30 mL) Gel
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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?
47764 Wound hydrogel dressing, non-antimicrobial
A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MGQ Dressing, wound and burn, hydrogel w/drug and/or biologic
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No 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: 4 Inch
Total Volume: 30 Milliliter
Width: 4 Inch
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Device Record Status
229ebd60-b9b6-4792-9fea-1e4f2d3cfb9b
April 17, 2023
6
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
20884521021928 25 10884521021921 2023-04-15 Not in Commercial Distribution PACK_OR_INNER_PACK
30884521021925 100 10884521021921 2023-04-15 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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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