Dermapose Access

GUDID 00850034511306

A pre-assembled, sterile, single use system intended to assist the harvesting of autologous fat grafts from a patient for aesthetic body contouring. It creates a guided incision for cannula introduction at a controlled depth (10 mm) under the skin for the purpose of small volume adipose tissue harvest.

Bimini Technologies LLC

Resective skin contouring/liposuction system depth guide
Primary Device ID00850034511306
NIH Device Record Key8852d940-0bfa-48e7-a07f-9c8acfdb71d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameDermapose Access
Version Model NumberACCESS
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
GS100850034511306 [Primary]

FDA Product Code

QPBSystem, Suction, Lipoplasty For Removal

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

Devices Manufactured by Bimini Technologies LLC

00850034511993 - DIRECT2 Lid2024-10-14 This device fits onto the Medela 3000cc Vacuum Canister, an off-the-shelf medical-grade vacuum canister. The DIRECT2 connects an
00850034511009 - Puregraft 850 System Twin Pack2024-08-30 A sterile, single use, closed polyolefin bag contains two polyester meshes and breached by valves for use in harvesting, filteri
00850034511153 - Puregraft Serene Breast Implant2024-04-05 Saline Breast Implant
00850034511337 - Puregraft Serene Breast Implant2024-04-05 Saline Breast Implant
00850034511399 - Puregraft Serene Breast Implant2024-04-05 Saline Breast Implant
00850034511627 - Puregraft Serene Breast Implant2024-04-05 Saline Breast Implant
00850034511658 - Puregraft Serene Breast Implant2024-04-05 Saline Breast Implant
00850034511672 - Puregraft Serene Breast Implant2024-04-05 Saline Breast Implant

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