FDA UDI
In Commercial Distribution
🇺🇸 United States
SoftFil® EasyGuide
DI: 10669808002394
·
Model: CEGS2250U
·
Prollenium Medical
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- SoftFil® EasyGuide
- Primary DI
- 10669808002394
- Version / Model
- CEGS2250U
- Company Name
- Prollenium Medical
- Labeler DUNS
- 247326606
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2022-08-11
- Public Version
- 1
- Public Version Date
- 2022-08-19
- Public Version Status
- New
- Public Device Record Key
- 50c811f2-8dba-4974-955b-25ca0864bc08
Device Description
SoftFil® EasyGuide is a sterile and single use injection kit containing: - 1 stainless steel EasyGuide pre-hole needle in its protective cap, - 1 stainless steel blunt-tip needle (micro-cannula) 22G x 50 mm graduated every centimeter along the tube in its protective cap.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 10669808002394 | GS1 | ||||
| Unit of Use | 10669808002097 | GS1 |