FDA UDI
In Commercial Distribution
🇺🇸 United States
Henso
DI: 06970343581600
·
Model: Acne Patch
·
Henso Medical (Hangzhou) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Henso
- Primary DI
- 06970343581600
- Version / Model
- Acne Patch
- Company Name
- Henso Medical (Hangzhou) Co., Ltd.
- Labeler DUNS
- 421316098
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-14
- Public Version
- 1
- Public Version Date
- 2023-02-22
- Public Version Status
- New
- Public Device Record Key
- 75580714-6d16-4369-b315-76e8034792dc
Device Characteristics
- Single Use
- Yes
- 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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | 878.4018 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60306 | Inflammatory skin/nerve/joint disorder dressing | A substance (e.g., cream, gel, solution, ointment) intended to be topically applied to the skin primarily to treat inflammatory disorders of the skin, nerves, and/or joints caused by a variety of disorders/insults (e.g., chronic inflammatory skin disorders, radiotherapy induced irritation, varicose veins, nappy rash, neuropathy, arthritis) to help reduce inflammation/irritation and associated symptoms through a physical mechanism; it may also be intended for prophylactic use and is not intended for application to open wounds. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06970343581600 | GS1 |