FDA UDI
In Commercial Distribution
🇺🇸 United States
Huibo Medical
DI: 06936943404022
·
Model: 15g
·
Henan Huibo Medical Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Huibo Medical
- Primary DI
- 06936943404022
- Version / Model
- 15g
- Company Name
- Henan Huibo Medical Co.,Ltd.
- Labeler DUNS
- 560455084
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-21
- Public Version
- 2
- Public Version Date
- 2024-02-16
- Public Version Status
- Update
- Public Device Record Key
- e70e8d50-becf-4227-8a00-83f45ab30c65
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PFP | Silicone Hydrogel For Scar Management | General, Plastic Surgery | 878.4025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06936943404022 | GS1 |