DEVICE: Huibo Medical (06936943403100)
Device Identifier (DI) Information
Huibo Medical
6cm*8cm
In Commercial Distribution
Henan Huibo Medical Co.,Ltd.
6cm*8cm
In Commercial Distribution
Henan Huibo Medical Co.,Ltd.
1.Comfortable and adhesive: Soft silicone with excellent performance; comfortable; stripping without pain; no skin irritation.
2.Slim and light: 0.5mm thickness.
3.Invisible and sun-resistant. Close to skin-color; good concealment; strong exclusive.; external use without affecting beauty .
4.Flexible and elastic.
5.Easy to cut: Before use, it can be cut economically according to the size of the scar.
6.Able to reuse. There is no skin allergy for long time use everyday. Normally, it can be used one week or so.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MDA | Elastomer, Silicone, For Scar Management |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f484633a-f078-45a8-8e67-a73f02d2954d
February 16, 2024
2
January 20, 2020
February 16, 2024
2
January 20, 2020
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
06936943403056
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined