FDA UDI
In Commercial Distribution
🇺🇸 United States
GA-F3A
DI: 08800067700071
·
Model: GA-F3A
·
AGNES MEDICAL CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- GA-F3A
- Primary DI
- 08800067700071
- Version / Model
- GA-F3A
- Company Name
- AGNES MEDICAL CO., LTD.
- Labeler DUNS
- 987426048
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2023-07-14
- Public Version
- 2
- Public Version Date
- 2026-04-28
- Public Version Status
- Update
- Public Device Record Key
- f7175d3a-eec9-45af-bedf-27b483eb3ffa
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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66286 | Intradermal radio-frequency ablation system needle electrode | An electrical conductor intended to be introduced into the dermal layer of the skin (intradermal) to deliver radio-frequency (RF) current in a monopolar configuration 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 intended to be used in conjunction with an appropriate RF generator and attached to a probe handle (not included). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 18800067700078 | GS1 | ||||
| Primary | 08800067700071 | GS1 |
Customer Contacts
- Phone
- +823180209717
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171707 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 80 Percent (%) Relative Humidity