Foundation DRS Solo

GUDID 00850047730053

Fenestrated

Bionova Medical Inc.

Wound regenerating polysaccharide agent
Primary Device ID00850047730053
NIH Device Record Key24b5cf50-4d38-4f06-ae4a-af210367ffb9
Commercial Distribution StatusIn Commercial Distribution
Brand NameFoundation DRS Solo
Version Model NumberFS1-F-1012
Company DUNS080325588
Company NameBionova Medical Inc.
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

Customer Support Contacts

Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com
Phone9017482581
Emailinfo@bionovamedical.com

Device Dimensions

Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter
Length10 Centimeter
Width12.5 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850047730053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug
FTMMesh, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-13
Device Publish Date2023-07-05

On-Brand Devices [Foundation DRS Solo]

00850047730077Fenestrated
00850047730060Fenestrated
00850047730053Fenestrated
00850047730046Fenestrated
00850047730039FS1-2025
00850047730022FS1-1025
00850047730015FS1-1012
00850047730008FS1-0505

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