Dermapose Refresh

GUDID 00850034511252

A sterile, single use microsizing syringe system intended for the harvesting, concentrating, and transferring of autologous adipose tissue back to the same patient when the transfer of harvested adipose tissue is desired. It consists of a 50 mL vacuum-lock syringe with a built-in, 800 micron filter for screening the tissue particle size to allow for easier injection through small, 18-21G injectors.

Bimini Technologies LLC

Autologous adipose tissue collection/washing set
Primary Device ID00850034511252
NIH Device Record Keye15bfc6b-9b88-4ff5-98a6-276e79e974a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDermapose Refresh
Version Model NumberREFRESH
Company DUNS076649467
Company NameBimini Technologies 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850034511252 [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 Date2022-02-17
Device Publish Date2022-02-09

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