FDA.reportPublic FDA data

Foundation DRS+ Duo

Primary DI
00850047730121
Brand
Foundation DRS+ Duo
Company
Bionova Medical Inc.
Model
802-1012
Published
2024-08-26
Public version status
New
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240298000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240298000Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc.2024-08-21FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850047730121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047730121008500477301218500477301210850047730121

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
00850047730015Foundation DRS SoloFS1-10122023-07-05
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415386MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415393MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677289MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677296MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
10840330706688ProCureTwin Med, LLCFRO2026-05-04
09551012610035ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610196ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610363ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610370ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
10192253046519KendallCardinal Health 200, LLCFRO2026-03-25
09120073781536GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781543GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781550GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781567GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781574GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
10197344169412MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169443MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-12-05
10197344169467MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169474MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169481MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169498MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344169504MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-11-07
10197344170197MEDLINEMEDLINE INDUSTRIES, INC.FRO2025-10-13
10192253046274KendallCardinal Health 200, LLCFRO2025-09-22
10192253047837XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047844XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047851XeroformCardinal Health 200, LLCFRO2025-09-22