DEVICE: Kendall (10884521021938)

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Device Record History
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Device Identifier (DI) Information
Kendall
9257
Not in Commercial Distribution
9257
Cardinal Health, Inc.
10884521021938
GS1
April 15, 2023
1
080935429 *Terms of Use
Hydrogel Impregnated Gauze,USP Type VII Gauze Pad 2.0 oz (59 mL) Gel
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
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?
46854 Wound-nonadherent dressing, absorbent, non-antimicrobial
A wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. 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
Total Volume: 59 Milliliter
Width: 4 Inch
Length: 8 Inch
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Device Record Status
cbd68ced-b977-4d8a-8211-aad5d4a66fdf
April 17, 2023
7
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
30884521021932 100 10884521021938 2023-04-15 Not in Commercial Distribution CASE
20884521021935 25 10884521021938 2023-04-15 Not 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: 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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