FDA.reportPublic FDA data

Foundation DRS+ Duo

Primary DI
00850047730152
Brand
Foundation DRS+ Duo
Company
Bionova Medical Inc.
Model
902-0505
Device description
Perforated
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
00850047730152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047730152008500477301528500477301520850047730152

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
Length5Centimeter
Width5Centimeter

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
00850047730121Foundation DRS+ Duo802-10122024-08-26
00850047730138Foundation DRS+ Duo802-10252024-08-26
00850047730145Foundation DRS+ Duo802-20252024-08-26
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
04260056880650BLASTXOSARTIS GmbHFRO2026-07-12
00850088144604CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144611CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144628CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850088144635CARBOUNingbo kehu Medical Technology Co.,Ltd.FRO2026-07-10
00850019138146SilverSealNEXGEL Inc.FRO2026-07-08
00850019138153TurfGuardNEXGEL Inc.FRO2026-07-08
00850019138443SilverSealNEXGEL Inc.FRO2026-07-08
00850019138474SilverSealNEXGEL Inc.FRO2026-07-08
00850019138511SilverSealNEXGEL Inc.FRO2026-07-08
00850067990086Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990178Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990260Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990352Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990444Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990536Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990628Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990710Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990802Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990895Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
10884389161562MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-06
00361470000175Amerigel Saline Wound WashAmerx Health Care Corp.FRO2026-06-22
00050428280669CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-06-04
00050428453599CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-06-04
50192253067901ASOCardinal Health 200, LLCFRO2026-06-03
00714196111050DermaRite Medical DermaHoney Medical Grade Honey 0.5 oz TubeSion Brands LLCFRO2026-06-01
00714196111074DermaRite Medical DermaHoney Medical Grade Honey 1.75 oz TubeSion Brands LLCFRO2026-06-01
01714196222045DermaRite Medical DermaHoney Tulle Non Border Honey Gauze 4x4Sion Brands LLCFRO2026-06-01
01714196333048DermaRite Medical DermaHoney Border Medical Grade Honey Sheet 4x4Sion Brands LLCFRO2026-06-01
08717249680130DermaRite Medical L-Mesitran 0.5 oz TubeSion Brands LLCFRO2026-06-01