FDA.reportPublic FDA data

RV-X1

Primary DI
00850058790114
Brand
RV-X1
Company
Gel4med, Inc.
Model
Dispenser Box, 2mL
Published
2025-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug
KGNWound Dressing With Animal-Derived Material(S)
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU
KGNWound Dressing With Animal-Derived Material(S)UnknownU
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222025000G4Derm / G4Derm Plus Synthetic Wound MatrixGel4med, Inc.2023-10-11FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850058790114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850058790114008500587901148500587901140850058790114

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic wound matrix dressingA sterile bioabsorbable device designed to be applied to hard-to-heal wounds (e.g., diabetic and venous insufficiency ulcers) or burns that involve the dermis, and that provides a matrix of structural synthetic fibres to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration; it may in addition be intended to facilitate regeneration of hard tissues such as bone (e.g., in cases of osteomyelitis) and may provide wound exudate absorbency. It does not contain biological materials. This is a single-use device.

Regulatory Flags#

DUNS number
079722830
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850058790121RV-X12 mL Pre-Filled Syringe (Sterile)2025-10-17
00850058790138G4Derm PlusDispenser Box, 2mLG4M200M2025-10-17
00850058790145G4Derm Plus2 mL Pre-Filled Syringe (Sterile)2025-10-17
00850058790152G4Derm PlusApplicator Tip (Sterile)2025-10-17
00850058790060SuprelloDispenser Box (2 mL Pre-Filled Syringe + Applicato2025-03-25
00850058790084Suprello2 mL Pre-Filled Syringe (Sterile)2025-03-25
00850058790091SuprelloApplicator Tip (Sterile)2025-03-25
00850058790008G4Derm Plus Synthetic Wound Matrix2 mL Pre Filled Syringe (Sterile)2024-03-13
00850058790015G4Derm Plus Synthetic Wound Matrix Applicator Tip (Sterile)2024-03-13
00850058790022G4Derm Plus Synthetic Wound Matrix Dispenser Box [Pre Filled Syringe (Sterile), Appli2024-03-13

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Primary DI, Brand, Company table
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09421908222591Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
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09421908222669Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222676Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222683Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
09421908222690Symphony OPX™ Proliferative BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-10-20
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07610221017621DermaFormGeistlich Pharma AGKGN2026-10-19
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00810226442979Vive CareVIVE HEALTH LLCKGN2026-10-14
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