Foundation DRS Solo

GUDID 00850047730312

Bionova Medical Inc.

Wound regenerating polysaccharide agent
Primary Device ID00850047730312
NIH Device Record Key169582a4-7d02-4b61-9839-df97da2a0399
Commercial Distribution StatusIn Commercial Distribution
Brand NameFoundation DRS Solo
Version Model NumberFS1-0009
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

Phone901-7482581
Emailinfo@bionovamedical.com
Phone901-7482581
Emailinfo@bionovamedical.com
Phone901-7482581
Emailinfo@bionovamedical.com
Phone901-7482581
Emailinfo@bionovamedical.com
Phone901-7482581
Emailinfo@bionovamedical.com
Phone901-7482581
Emailinfo@bionovamedical.com
Phone901-7482581
Emailinfo@bionovamedical.com
Phone901-7482581
Emailinfo@bionovamedical.com

Device Dimensions

Area/Surface Area9 Square centimeter
Area/Surface Area9 Square centimeter
Area/Surface Area9 Square centimeter
Area/Surface Area9 Square centimeter
Area/Surface Area9 Square centimeter
Area/Surface Area9 Square centimeter
Area/Surface Area9 Square centimeter
Area/Surface Area9 Square centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850047730312 [Primary]

FDA Product Code

FTMMesh, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-25
Device Publish Date2025-09-17

On-Brand Devices [Foundation DRS Solo]

00850047730077Fenestrated
00850047730060Fenestrated
00850047730053Fenestrated
00850047730046Fenestrated
00850047730039FS1-2025
00850047730022FS1-1025
00850047730015FS1-1012
00850047730008FS1-0505
00850047730343FS1-20252
00850047730336FS1-0404
00850047730329FS1-0203
00850047730312FS1-0009
00850047730305FS1-0003

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