FDA UDI
In Commercial Distribution
🇺🇸 United States
1NEED Pro Cartridges
DI: 08055598060075
·
Model: NF9MN0.18 2.5mm
·
CAMPOMATS SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- 1NEED Pro Cartridges
- Primary DI
- 08055598060075
- Version / Model
- NF9MN0.18 2.5mm
- 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
- ce17d2f5-dd37-41fa-a32c-1ed5c43b0c28
Device Description
Box of 10 NOFLOW® Cartridges + 10 Protective sleeves to be used in combination with 1NEED Pro device.
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| QAI | Powered Microneedle Device | General, Plastic Surgery | 878.4430 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61222 | Cosmetic micro-needling electronic handpiece cartridge, professional | A device intended to be fitted to an electronic cosmetic micro-needling handpiece for the creation of high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It is a small, sealed cartridge containing micro-needles intended to be fitted to the distal tip of the handpiece; it does not include any injectable materials. It is intended to be used by a healthcare provider in a clinical setting. It is not intended to be used for energy-based skin treatment. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08055598060082 | GS1 | cardboard box | 400 | In Commercial Distribution | |
| Primary | 08055598060075 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243472 | 000 |