FDA UDI
In Commercial Distribution
🇺🇸 United States
Virtue RF Microneedle Cartridge
DI: 08800017100722
·
Model: SmartRF 36PIN TIP
·
shenb Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Virtue RF Microneedle Cartridge
- Primary DI
- 08800017100722
- Version / Model
- SmartRF 36PIN TIP
- Company Name
- shenb Co., Ltd.
- Labeler DUNS
- 690425442
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-12-10
- Public Version
- 1
- Public Version Date
- 2020-12-18
- Public Version Status
- New
- Public Device Record Key
- 5f7aa95e-56e1-4f1a-921e-743f25aeaf7c
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| OUH | Skin Resurfacing Rf Applicator | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58454 | Radio-frequency skin surface treatment system | An assembly of devices designed to apply radio-frequency (RF) energy to heat the skin surface for ablation, coagulation, and tightening of the skin’s outer later (stratum corneum) for aesthetic skin resurfacing. It primarily consists of a mains electricity (AC-powered) control unit to produce and regulate the RF energy, and a connected bipolar RF applicator (handpiece) to deliver the RF energy to the skin surface; the applicator may include vacuum to facilitate its coupling with the skin. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800017100722 | GS1 | ||||
| Unit of Use | 08800017100739 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150409 | 000 |