FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Bristle needles
DI: 18657300002204
·
Model: 27G, 33G
·
AP MEDESTHETICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bristle needles
- Primary DI
- 18657300002204
- Version / Model
- 27G, 33G
- Company Name
- AP MEDESTHETICS, INC.
- Labeler DUNS
- 056296605
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-06
- Public Version
- 4
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- 89c6962c-9349-4d63-8d90-6ff57d9f2f52
- Distribution End Date
- 2019-11-27
Device Description
The single piece device is a plastic handle fused to a stainless-steel needle, insulated to the tip. The other end of the plastic handle is fused to a flexible lead wire and a “touch-proof” safety connector. The device is used to transfer RF energy from the VeinGogh generator to the spider vein.
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
- No
- 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 |
|---|---|---|---|---|
| GXZ | Electrode, Needle | Neurology | 882.1350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63686 | Intradermal radio-frequency ablation system probe | A hand-held surgical instrument intended to be introduced into the dermal layer of the skin (intradermal) to deliver radio-frequency current in a monopolar configuration from a system generator for coagulation/ablation to treat skin conditions [typically superficial skin lesions (e.g., telangiectasia, cherry angioma, venous lake, skin tags) and/or acne]. It is comprised of an insulated handle with a thin, distal, monopolar electrode. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18657300002204 | GS1 |