FDA UDI
In Commercial Distribution
🇺🇸 United States
EZ SCULPT
DI: 00860009682191
·
Model: EZ-2005
·
Jordan Consulting Group, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
25
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Basic Information
- Brand Name
- EZ SCULPT
- Primary DI
- 00860009682191
- Version / Model
- EZ-2005
- Company Name
- Jordan Consulting Group, LLC
- Labeler DUNS
- 080664909
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2023-02-24
- Public Version
- 1
- Public Version Date
- 2023-03-06
- Public Version Status
- New
- Public Device Record Key
- 11695d91-3b0d-438c-a0ba-bed4bc822e61
Device Description
EZ Sculpt Disp. Microcannula, 27x1 1/2 (27x38mm)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | 00860009962941 | GS1 | Box | 20 | In Commercial Distribution | |
| Primary | 00860009682191 | GS1 | ||||
| Package | 00860009941441 | GS1 | Carton | 4 | In Commercial Distribution | |
| Unit of Use | 00860009941496 | GS1 |
Customer Contacts
- Phone
- 786-547-8166
- [email protected]