FDA UDI
In Commercial Distribution
🇺🇸 United States
DISPOSABLE MICRO CANNULA FOR FILLER INJECTION
DI: 03760037735142
·
Model: 26gauge x 5 cm - 1-hole
·
AESTHETIC GROUP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DISPOSABLE MICRO CANNULA FOR FILLER INJECTION
- Primary DI
- 03760037735142
- Version / Model
- 26gauge x 5 cm - 1-hole
- Catalog Number
- MI2650KR
- Company Name
- AESTHETIC GROUP
- Labeler DUNS
- 260069352
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-16
- Public Version
- 3
- Public Version Date
- 2019-12-12
- Public Version Status
- Update
- Public Device Record Key
- 55fc1a9f-6ce4-44ae-bdba-6746beb77014
Device Description
Flexible micro cannulas to inject a filler (synthetic or autologous fat) under the skin.
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 |
|---|---|---|---|---|
| GEA | Cannula, Surgical, General & Plastic Surgery | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46676 | Tissue injection cannula | A thin, sterile, semi-rigid or rigid metal tube intended to be inserted percutaneously for the injection of a substance into the cutaneous or subcutaneous layers. It is typically used for the administration of fillers [e.g., hyaluronic acid (HA)] to add volume to tissue for cosmetic or reconstructive purposes. The device is typically designed with a closed-off nose and a lateral hole at the distal tip, and a connector at the proximal end for attachment to a device that propels the injection substance. It is typically made of high-grade stainless steel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03760037735135 | GS1 | Box | 20 | In Commercial Distribution | |
| Primary | 03760037735142 | GS1 |