DEVICE: CicaCare 12cm x 6cm Ctn of 1 Global (05000223441586)

Device Identifier (DI) Information

CicaCare 12cm x 6cm Ctn of 1 Global
66250704
In Commercial Distribution
66250704 & 66250705
SMITH & NEPHEW MEDICAL LIMITED
05000223441586
GS1

1
216344051 *Terms of Use
Silicone Gel Sheet. Treatment for red and raised, old and new scars
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
44898 Scar-management dressing, reusable
A covering made of, or coated with, a synthetic polymer material (e.g., silicone gel) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of an elastic sheet that occludes the skin to hydrate and reduce red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; it may be washable. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MDA Elastomer, Silicone, For Scar Management
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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

90e4a968-af06-4573-bdfd-072f10e5a398
February 16, 2024
4
February 12, 2021
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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
05000223441784 1 05000223441586 In Commercial Distribution Carton
05000223441791 20 05000223441784 In Commercial Distribution Case
05000223441807 40 05000223441784 In Commercial Distribution Case 66250705
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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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