DEVICE: Huibo Medical (06936943404022)

Device Identifier (DI) Information

Huibo Medical
15g
In Commercial Distribution

Henan Huibo Medical Co.,Ltd.
06936943404022
GS1

1
560455084 *Terms of Use
medical polymer materials imported from USA polymer gel- biological adhesion gel imported from overseas. hydrogel matrix-fine and smooth. Proper consistency and thickness; do not pollute clothing and easy to cleaning for non-greasy; odourless and colorless, can inject quickly into the skin by rubbing. a thin transparent film which is breathable and waterproof can be formed after applying this product to the scar. Not only ensure breath to the skin, but also promote metabolize and lock water to soft scar and eliminate discomfort. Effect of relieving itching.
CLOSE

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
PFP Silicone Hydrogel For Scar Management
CLOSE

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
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

e70e8d50-becf-4227-8a00-83f45ab30c65
February 16, 2024
2
January 21, 2020
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE