FDA.reportPublic FDA data

Puregraft

Primary DI
00863445000314
Brand
Puregraft
Company
PUREGRAFT LLC
Model
850
Catalog number
850/PURE
Device description
Puregraft 850 System
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUUSystem, Suction, Lipoplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUUSystem, Suction, LipoplastyGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113255000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113255000PUREGRAFT 850/PURE SYSTEMCytori Therapeutics, Inc.2012-03-07MUU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10863445000311PackageGS15Not in Commercial Distribution
00863445000314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086344500031110863445000311
00863445000314008634450003148634450003140863445000314

GMDN Terms#

Term, Definition table
TermDefinition
Autologous adipose tissue noninvasive processing setA 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.

Contacts#

Phone, Email table
PhoneEmail
858-348-8050info@puregraft.com

Regulatory Flags#

DUNS number
079508934
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860407002218Puregraft250250/PURE2019-12-06
00860407002225Puregraft850850/PURE2019-05-14
00863445000307Puregraft250250/PURE2016-09-22
00863445000338Puregraft5050/PURE2016-09-22
00863445000352Dermapose RefreshREFRESH2020-08-24
00863445000369Dermapose AccessACCESS2020-08-24
00850009190130AutoPose RestoreABS-101035-12023-01-04
00860407002287Puregraft MicroFat Transfer Kit (19G)50/MICRO192020-08-24
00860407002294Puregraft MicroFat Transfer Kit (21G)50/MICRO212020-08-24
00860407002232Dermapose Refresh Syringe StandSTAND2020-08-21
00860407002270Puregraft MicroFat Transfer Kit50/MICRO2020-03-18
10863445000359Dermapose RefreshREFRESH2020-08-24
10863445000366Dermapose AccessACCESS2020-08-24
10860407002215Puregraft250250/PURE2019-12-06
10860407002222Puregraft850850/PURE2019-05-14
20863445000301Puregraft250250/PURE2016-09-22
10863445000311Puregraft850850/PURE2016-09-22
00863445000345Puregraft5050/PURE2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810130455843Medco ManufacturingMedco Manufacturing LLCMUU2026-03-31
04260632793640TLA Tubing Liposat Pro plusMöller Medical GmbHMUU2026-02-27
04260632794043TLA Tubing Liposat Pro plusMöller Medical GmbHMUU2026-02-27
00850000712478Autoclavable Suction Jar with Hose Barb extension - 250mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712485Autoclavable Suction Jar with Hose Barb extension - 500mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712492Autoclavable Suction Jar with Hose Barb extension - 1000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712508Autoclavable Suction Jar with Hose Barb extension - 2000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00850000712515Autoclavable Suction Jar with Hose Barb extension - 3000mLMillennium Medical Technologies, Inc.MUU2026-01-29
00810130455812Medco ManufacturingMedco Manufacturing LLCMUU2026-01-15
00810130455829Medco ManufacturingMedco Manufacturing LLCMUU2026-01-15
00810130455485Medco ManufacturingMedco Manufacturing LLCMUU2025-09-11
00810130455195Medco ManufacturingMedco Manufacturing LLCMUU2025-06-26
00810130455201Medco ManufacturingMedco Manufacturing LLCMUU2025-06-26
08800052308909FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
08800052308886FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
08800052316904FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
00810130454839Medco ManufacturingMedco Manufacturing LLCMUU2025-02-27
00385640084987SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640084994SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085007SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085014SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
00385640085021SUMMIT MEDICALSummit Medical, Inc.MUU2025-01-22
03760173235292DISPOSABLE FAT HARVESTING CANNULAAESTHETIC GROUPMUU2024-12-09
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGMUU2024-05-31
07612367003551Quiver 280mmMedela AGMUU2024-05-31
07612367003568Quiver 480mmMedela AGMUU2024-05-31
07612367003698Overflow protection deviceMedela AGMUU2024-05-31
07612367003735Reusable serial connectorMedela AGMUU2024-05-31
07612367003742Safety Set for railholderMedela AGMUU2024-05-31
07612367003896Tubing holder left sideMedela AGMUU2024-05-31