DEVICE: Canker-X Mouth Sore Gel (00358962301001)

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Device Record History
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Device Identifier (DI) Information
Canker-X Mouth Sore Gel
Lot Code
In Commercial Distribution

Alliance Pharma Inc.
00358962301001
GS1

1
081138954 *Terms of Use
Canker-X Mouth Sore Gel 8ml
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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?
47943 General oral wound dressing, non-animal-derived
A compound intended to be used as a protective cover for the general oral mucosa to treat mouth wounds and sores such as ulcers and lesions caused by trauma, surgery, radiotherapy/chemotherapy or dental prostheses/orthodontic braces; it may in addition be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis, or to prevent mouth wounds/lesions. It consists primarily of one or more plant-derived and/or (bio)synthetic compound(s) [e.g., polysaccharides, hyaluronic acid, dimethicone] and is supplied in various forms (e.g., plug, sheet, gel, fluid, spray) for use in the home and clinical setting. After application, this device cannot be reused.
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 [?]
K040950 000
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Sterilization
No
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
fe639905-3681-48ed-b43d-8ca9b31b8c33
April 10, 2024
1
April 02, 2024
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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
No Package DIs found
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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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