FDA UDI
In Commercial Distribution
🇺🇸 United States
Infiltration kit
DI: 03760173233694
·
Model: 1
·
AESTHETIC GROUP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Infiltration kit
- Primary DI
- 03760173233694
- Version / Model
- 1
- Catalog Number
- PACK001-BI
- Company Name
- AESTHETIC GROUP
- Labeler DUNS
- 260069352
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-15
- Public Version
- 1
- Public Version Date
- 2021-08-23
- Public Version Status
- New
- Public Device Record Key
- abbcd198-4a9f-4ce3-9dc5-ba86976aa538
Device Description
This kit is a convenience kit. The devices contained in the infiltration kit are used to collect fat tissue. The procedure usually involves infiltration of tumescent solution before harvesting fat tissue by liposuction.
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 |
|---|---|---|---|---|
| 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 | 03760173233700 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 03760173233694 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius