Dermapose Refresh

GUDID 10863445000359

PUREGRAFT LLC

Autologous adipose tissue collection/washing set
Primary Device ID10863445000359
NIH Device Record Key3e5cdcf5-8679-4a11-8790-d6b814b0c77d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDermapose Refresh
Version Model NumberREFRESH
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
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
GS100863445000352 [Primary]
GS110863445000359 [Package]
Contains: 00863445000352
Package: Case [24 Units]
In Commercial Distribution

FDA Product Code

MUUSystem, Suction, Lipoplasty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-11-22
Device Publish Date2020-08-24

Devices Manufactured by PUREGRAFT LLC

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
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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