FDA UDI
In Commercial Distribution
🇺🇸 United States
AUVON
DI: 06971292003700
·
Model: SAS0410
·
Shenzhen Yuwen E-Commerce Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- AUVON
- Primary DI
- 06971292003700
- Version / Model
- SAS0410
- Company Name
- Shenzhen Yuwen E-Commerce Co., Ltd.
- Labeler DUNS
- 544559614
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-19
- Public Version
- 1
- Public Version Date
- 2025-06-27
- Public Version Status
- New
- Public Device Record Key
- a7be5bee-743a-4abf-988e-38f48d2bd98f
Device Description
It is used to cover non-chronic wound surfaces and absorb wound exudate.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | General, Plastic Surgery | 878.4022 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47764 | Wound hydrogel dressing, non-antimicrobial | A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16971292003707 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 06971292003700 | GS1 | ||||
| Package | 26971292003704 | GS1 | 15 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(678)829-7256
- [email protected]