FDA UDI
In Commercial Distribution
🇺🇸 United States
Puregraft 850 System Twin Pack
DI: 00850034511023
·
Model: 850/TWIN
·
Bimini Technologies LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Puregraft 850 System Twin Pack
- Primary DI
- 00850034511023
- Version / Model
- 850/TWIN
- Company Name
- Bimini Technologies LLC
- Labeler DUNS
- 076649467
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-22
- Public Version
- 2
- Public Version Date
- 2025-07-21
- Public Version Status
- Update
- Public Device Record Key
- 6bcd555a-46c0-4348-8b49-6d34fce72a7a
Device Description
A sterile, single use, closed polyolefin bag contains two polyester meshes and breached by valves for use in harvesting, filtering, and transferring autologous fat tissue for reinjecting back into the same patient. Two bags included per packaging unit.
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
- No
- 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 |
|---|---|---|---|---|
| 56627 | Autologous adipose tissue noninvasive processing set | A noninvasive collection of non-powered devices designed as a closed system for the collection and processing (e.g., filtering, washing) of autologous fat tissue for reinjection into the patient from whom it was taken (autologous lipotransfer) for aesthetic body contouring. It consists of containers (typically filtration and waste collection bags) and connection accessories (e.g., connectors, tubing); it does not include invasive needles/cannulae. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850034511009 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00850034511023 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| BK220693 | 0 |