FDA UDI
In Commercial Distribution
🇺🇸 United States
PACK-EVOSKIN
DI: 03760173235216
·
Model: 1
·
AESTHETIC GROUP
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- PACK-EVOSKIN
- Primary DI
- 03760173235216
- Version / Model
- 1
- Company Name
- AESTHETIC GROUP
- Labeler DUNS
- 260069352
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-05
- Public Version
- 3
- Public Version Date
- 2025-07-21
- Public Version Status
- Update
- Public Device Record Key
- fae44bb4-d647-447f-a466-64c140ca7abf
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
- 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 reinjection set | A collection of devices which includes an invasive cannula/needle, intended for both harvesting fat tissue from a patient (liposuction) and subsequently injecting the fat tissue into the patient from whom it was taken (autologous lipotransfer) as part of a surgical procedure (e.g., reconstructive/cosmetic, orthopaedic, spinal); it may additionally be intended to process the adipose tissue. In addition to needles/cannulae, it includes syringes, accessories (e.g., caps, connectors), and may include collection/processing devices (e.g., filtration bag). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03760173235216 | GS1 | ||||
| Package | 03760173235223 | GS1 | Box | 8 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 30 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry