FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Puregraft
DI: 00860407002225
·
Model: 850
·
PUREGRAFT LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Puregraft
- Primary DI
- 00860407002225
- Version / Model
- 850
- Catalog Number
- 850/PURE
- Company Name
- PUREGRAFT LLC
- Labeler DUNS
- 079508934
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-14
- Public Version
- 4
- Public Version Date
- 2025-07-21
- Public Version Status
- Update
- Public Device Record Key
- b7eab9a2-60a4-4fc7-b3a6-6463929a56a1
- Distribution End Date
- 2023-05-24
Device Description
Puregraft 850 System (Made in USA)
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 |
|---|---|---|---|---|
| MUU | System, Suction, Lipoplasty | 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 | 10860407002222 | GS1 | Case | 5 | Not in Commercial Distribution | 2023-05-24 |
| Primary | 00860407002225 | GS1 |
Customer Contacts
- Phone
- 858-348-8050
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113255 | 000 |