FDA UDI
In Commercial Distribution
🇺🇸 United States
Adinizer
DI: 08800080202200
·
Model: SKT-AN-6020
·
BSL Co.,Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Adinizer
- Primary DI
- 08800080202200
- Version / Model
- SKT-AN-6020
- Company Name
- BSL Co.,Ltd
- Labeler DUNS
- 694860273
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-11
- Public Version
- 3
- Public Version Date
- 2025-07-21
- Public Version Status
- Update
- Public Device Record Key
- 62c45cb6-8bfb-4c9f-8662-9f9dda34d97a
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 |
|---|---|---|---|---|
| QKL | Lipoaspirate Washing System For Aesthetic Body Contouring | General, Plastic Surgery | 878.5040 | 2 |
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 | 08800080202200 | GS1 |
Customer Contacts
- Phone
- +82553289235
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK220722 | 0 |