FDA.reportPublic FDA data

Renovar Advanced

Primary DI
50850025153947
Brand
Renovar Advanced
Company
HR PHARMACEUTICALS INC.
Model
60799
Catalog number
60799
Device description
Renovar Advanced Wound Irrigation Solution 250mL Instill/Spikeable Bottle
Published
2023-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, wound, drug

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50850025153947PackageGS112In Commercial Distribution
00850025153942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5085002515394750850025153947
00850025153942008500251539428500251539420850025153942

GMDN Terms#

Term, Definition table
TermDefinition
Non-antimicrobial wound irrigation solution, multiple soluteA solution of electrolytes sometimes with other compounds [not limited to sodium chloride (NaCl), therefore not a saline solution], intended to be used to irrigate and clean a superficial skin wound to support natural healing; it is not intended to provide antimicrobial activity. The device may be supplied in a plastic container with a spray nozzle and is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(717)252-1110sbenser@hrpharma.com

Regulatory Flags#

DUNS number
828918164
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50850058254673EZ-Advancer®AKC142026-03-06
50850058254680TruAdvance™TAC142026-03-06
10850067913006TruLockTLFS302026-03-06
10850067913013TruLockTLFS562026-03-06
50850058254451EZ-Protect™10108H2026-02-05
00850058254463EZ-Protect™10110H2026-02-05
50850058254475EZ-Protect™10112H2026-02-05
50850058254482EZ-Protect™10114H2026-02-05
50850058254499EZ-Protect™10116H2026-02-05
50850058254505EZ-Protect™10118H2026-02-05
50850058254512EZ-Protect™12108H2026-02-05
50850058254529EZ-Protect™12110H2026-02-05
50850058254536EZ-Protect™12112H2026-02-05
50850058254543EZ-Protect™12114H2026-02-05
50850058254550EZ-Protect™12116H2026-02-05
50850058254567EZ-Protect™12118H2026-02-05
50850045818468TruAdvance®FTDS14UM2025-12-22
50850045818475TruAdvance®FTDS16UM2025-12-22
50850045818482TruAdvance®FTDS18UM 2025-12-22
50850058254888TruAdvanceFTTS14UM2025-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00365197409105A+D Antimicrobial HydrogelSonoma Pharmaceuticals, Inc.FRO2026-05-25
00850087488006CeeportCEEPORT INC.FRO2026-05-22
10885632434266HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468490HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468506HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468513HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632468520HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509032HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509049HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509056HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632509063HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
10885632510199HalyardOWENS & MINOR DISTRIBUTION, INC.FRO2026-05-22
06977727072211Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072228Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072235Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072242Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072419SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072426SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072433SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
06977727072440SurCura Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-03-23
00050428339770CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-03-20
04719883980090Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980311Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980342Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980359Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980366Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980373Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980380Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
04719883980397Bonvadis Topical CreamONENESS BIOTECH CO., LTD.FRO2026-03-20
05060996770023AcutarexAlliance Healing Technologies, LLCFRO2026-03-13