FDA.reportPublic FDA data

Renovar Advanced

Primary DI
50850025153961
Brand
Renovar Advanced
Company
HR PHARMACEUTICALS INC.
Model
60781
Catalog number
60781
Device description
Renovar Advanced Wound Irrigation Solution 990mL 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
50850025153961PackageGS16In Commercial Distribution
00850025153966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5085002515396150850025153961
00850025153966008500251539668500251539660850025153966

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
00850025153027Vitus5205202021-05-19
00850025153034Vitus5215212021-05-19
00850025153041Vitus5225222021-05-19
00850025153089Vitus5135132023-03-31
00850058254333TruLockTLFC12025-03-03
00850058254364TruLockTLFC52025-03-03
00850058254371TruLockTLFCP2025-03-03
00850067913009TruLockTLFS302026-03-06
00850067913016TruLockTLFS562026-03-06
00850058254579LivLIV082026-03-30
00850058254586LivLIV102026-03-30
00850058254593LivLIV122026-03-30
00850058254609LivLiv142026-03-30
00850025153188MTG32108321082022-09-28
00850025153195MTG32110321102022-09-28
00850025153218MTG32112321122022-09-28
00850025153232MTG32114321142022-09-28
00851809002005HR Ultrasound Jelly212ST212ST2016-09-24
00851809002029EcoVue HV3803802020-09-21
00851809002043EcoVue HV3813812020-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
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
10192253047868XeroformCardinal Health 200, LLCFRO2025-09-22
10192253047806XeroformCardinal Health 200, LLCFRO2025-09-10
10192253046311KendallCardinal Health 200, LLCFRO2025-09-09
10192253046373KendallCardinal Health 200, LLCFRO2025-09-09
10192253046472KendallCardinal Health 200, LLCFRO2025-09-09
10192253046540KendallCardinal Health 200, LLCFRO2025-09-09