FDA.reportPublic FDA data

Foundation DRS Solo

Primary DI
00850047730015
Brand
Foundation DRS Solo
Company
Bionova Medical Inc.
Model
FS1-1012
Published
2023-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug
FTMMesh, Surgical
PMQPeripheral Blood Processing Device For Wound Management
QSZAbsorbable Synthetic Wound Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU
FTMMesh, SurgicalGeneral, Plastic Surgery2
PMQPeripheral Blood Processing Device For Wound ManagementHematology2
QSZAbsorbable Synthetic Wound DressingUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210949000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210949000Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.2022-08-11KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850047730015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047730015008500477300158500477300150850047730015

GMDN Terms#

Term, Definition table
TermDefinition
Wound regenerating polysaccharide agentA sterile device consisting primarily of polysaccharides intended to be used to facilitate the regeneration and repair of tissues affected by a chronic wound (e.g., diabetic foot ulcer, venous ulcer, arterial ulcer, pressure ulcer, bedsore) after wound debridement. It may be a solution or sheet containing extracellular matrix regenerating agents (engineered polymers designed to promote wound matrix regeneration) and/or structural elements for native cell attachment/proliferation; devices associated with tissue application/manipulation (e.g., sterile gauze, tweezers) may be included. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Centimeter
Width12.5Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9017482581info@bionovamedical.com

Regulatory Flags#

DUNS number
080325588
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850047730305Foundation DRS SoloFS1-00032025-09-17
00850047730312Foundation DRS SoloFS1-00092025-09-17
00850047730329Foundation DRS SoloFS1-02032025-09-17
00850047730336Foundation DRS SoloFS1-04042025-09-17
00850047730343Foundation DRS SoloFS1-202522025-09-17
00850047730008Foundation DRS SoloFS1-05052023-07-05
00850047730022Foundation DRS SoloFS1-10252023-07-05
00850047730039Foundation DRS SoloFS1-20252023-07-05
00850047730046Foundation DRS SoloFS1-F-05052023-07-05
00850047730053Foundation DRS SoloFS1-F-10122023-07-05
00850047730060Foundation DRS SoloFS1-F-10252023-07-05
00850047730077Foundation DRS SoloFS1-F-20252023-07-05
00850047730114Foundation DRS+ Duo802-05052024-08-26
00850047730121Foundation DRS+ Duo802-10122024-08-26
00850047730138Foundation DRS+ Duo802-10252024-08-26
00850047730145Foundation DRS+ Duo802-20252024-08-26
00850047730152Foundation DRS+ Duo902-05052024-08-26
00850047730169Foundation DRS+ Duo902-10122024-08-26
00850047730176Foundation DRS+ Duo902-10252024-08-26
00850047730183Foundation DRS+ Duo902-20252024-08-26

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Primary DI, Brand, Company table
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00841277111200Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111224Novera RenewHarps USA, Inc.FRO2026-08-26
00841277111323Novera RenewHarps USA, Inc.FRO2026-08-26
00850087488723CeeportCEEPORT INC.FRO2026-08-26
00850087488730CeeportCEEPORT INC.FRO2026-08-26
00850087488846CeeportCEEPORT INC.FRO2026-08-26
00850087488853CeeportCEEPORT INC.FRO2026-08-26
00850087488747CeeportCEEPORT INC.FRO2026-08-25
04260056880636BactisureOSARTIS GmbHFRO2026-08-25
05000223503284ACTICOAT FlexSMITH & NEPHEW MEDICAL LIMITEDFRO2026-08-25
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00197998433559Solventum™ Tegaderm™Solventum US LLCFRO2026-08-23
04046961025153Prontosan®B. BRAUN MEDICAL INC.FRO2026-08-09
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10197344169429MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
10197344169436MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-08-07
00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29