Puregraft 850/PURE
GUDID 10863445000311
Puregraft 850 System
PUREGRAFT LLC
Autologous adipose tissue collection/washing set| Primary Device ID | 10863445000311 |
| NIH Device Record Key | c458d7d4-848d-400b-824f-5aab56aa767d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Puregraft |
| Version Model Number | 850 |
| Catalog Number | 850/PURE |
| Company DUNS | 079508934 |
| Company Name | PUREGRAFT LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com | |
| Phone | 858-348-8050 |
| info@puregraft.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00863445000314 [Primary] |
| GS1 | 10863445000311 [Package] Contains: 00863445000314 Package: Case [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113255
FDA Product Code
| MUU | System, Suction, Lipoplasty |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-22 |
On-Brand Devices [Puregraft]
| 00863445000345 | Puregraft 50 System |
| 10863445000311 | Puregraft 850 System |
| 20863445000301 | Puregraft 250 System |
| 10860407002222 | Puregraft 850 System (Made in USA) |
| 10860407002215 | Puregraft 250 System (Made in USA) |
Trademark Results [Puregraft]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PUREGRAFT 87760609 5554305 Live/Registered |
PUREGRAFT LLC 2018-01-18 |
 PUREGRAFT 77905359 3945551 Dead/Cancelled |
PUREGRAFT LLC 2010-01-05 |
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