AutoPose Restore

GUDID 00850009190130

A sterile, single use microsizing syringe system intended for the harvesting, concentrating, and transferring of autologous fat tissue back to the same patient when the transfer of harvested adipose tissue is desired.

PUREGRAFT LLC

Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set Autologous adipose tissue collection/washing set
Primary Device ID00850009190130
NIH Device Record Key37f28a7e-db60-403d-a692-747f2a76c306
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutoPose Restore
Version Model NumberABS-101035-1
Company DUNS079508934
Company NamePUREGRAFT LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep package dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep package dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep package dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep package dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep package dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep package dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep package dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep package dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep package dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep package dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep package dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep package dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep package dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep package dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep package dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep package dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep package dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100850009190130 [Primary]

FDA Product Code

MUUSystem, Suction, Lipoplasty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-01-12
Device Publish Date2023-01-04

Devices Manufactured by PUREGRAFT LLC

00850009190130 - AutoPose Restore2023-01-12A sterile, single use microsizing syringe system intended for the harvesting, concentrating, and transferring of autologous fat tissue back to the same patient when the transfer of harvested adipose tissue is desired.
00850009190130 - AutoPose Restore2023-01-12 A sterile, single use microsizing syringe system intended for the harvesting, concentrating, and transferring of autologous fat
10863445000359 - Dermapose Refresh2021-11-22
10863445000366 - Dermapose Access2021-11-22
00860407002287 - Puregraft MicroFat Transfer Kit (19G)2020-09-01
00860407002294 - Puregraft MicroFat Transfer Kit (21G)2020-09-01
00860407002232 - Dermapose Refresh Syringe Stand2020-08-31
00860407002270 - Puregraft MicroFat Transfer Kit2020-03-26
10860407002215 - Puregraft2019-12-16 Puregraft 250 System (Made in USA)

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