FDA UDI
In Commercial Distribution
🇺🇸 United States
Kit lipofilling face
DI: 03701068808146
·
Model: PACK-GOLD
·
AESTHETIC GROUP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Kit lipofilling face
- Primary DI
- 03701068808146
- Version / Model
- PACK-GOLD
- Company Name
- AESTHETIC GROUP
- Labeler DUNS
- 260069352
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-14
- Public Version
- 2
- Public Version Date
- 2023-03-20
- Public Version Status
- Update
- Public Device Record Key
- 3682e3f0-c74c-4275-9d52-dfe7d75a67bb
Device Description
Kit lipofilling face
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
- 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 |
|---|---|---|---|---|
| FTN | Plastic Surgery And Accessories Kit | General, Plastic Surgery | 878.3925 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63046 | Autologous adipose tissue collection/injection set | A collection of sterile devices intended for both harvesting fat tissue from a patient and subsequently injecting the fat tissue into the patient from which it was taken (autologous) for aesthetic body contouring during reconstructive/cosmetic surgery. It typically consists of various needles/cannulae, syringes, and accessories (e.g., caps, connectors). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03701068808153 | GS1 | box | 5 | In Commercial Distribution | |
| Primary | 03701068808146 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius