FDA UDI
In Commercial Distribution
🇺🇸 United States
1NEED Pro
DI: 08055598060068
·
Model: ASCAMPOMATS_1NEED_MN_PRO
·
CAMPOMATS SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 1NEED Pro
- Primary DI
- 08055598060068
- Version / Model
- ASCAMPOMATS_1NEED_MN_PRO
- Company Name
- CAMPOMATS SRL
- Labeler DUNS
- 442208550
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-03
- Public Version
- 1
- Public Version Date
- 2025-12-11
- Public Version Status
- New
- Public Device Record Key
- 49728fbf-2784-41b8-8a80-0943ea1a2c8c
Device Description
Microneedling device. 1NEED Pro consists of Handpiece Holder - Power Supply with detachable cable - Instructions for Use
Device Characteristics
- Single Use
- No
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QAI | Powered Microneedle Device | General, Plastic Surgery | 878.4430 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61216 | Cosmetic micro-needling electronic handpiece, professional | A hand-held, electrically-powered device intended to be used in combination with a micro-needle cartridge (which contains micro-needles) to create high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It includes controls to allow for treatment adjustments (e.g., puncture depth, frequency); a disposable micro-needle cartridge may be included. It is intended for clinical use by a healthcare provider to treat stretch marks, acne scarring, hyperpigmentation, wrinkles, and/or hair loss; it is not intended for energy-based skin treatment. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08055598060051 | GS1 | carder box | 5 | In Commercial Distribution | |
| Primary | 08055598060068 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243472 | 000 |