FDA.reportPublic FDA data

Suprello

Primary DI
00850058790084
Brand
Suprello
Company
Gel4med, Inc.
Model
2 mL Pre-Filled Syringe (Sterile)
Published
2025-03-25
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

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
00850058790084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850058790084008500587900848500587900840850058790084

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic peptide haemostatic agentA sterile, bioabsorbable device containing synthetic peptides intended to be applied to a surgical site to rapidly facilitate local haemostasis primarily through formation of a peptide hydrogel; it does not contain an antimicrobial agent. It is typically available as an aqueous solution (e.g., prefilled syringe) that can be applied directly to the wound where it remains to be absorbed by the body. This is a single-use device.

Sterilization Methods#

Method table
Method

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
00850058790114RV-X1Dispenser Box, 2mL2025-10-17
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852421007683Pure&CleanPure & Clean, LLCFRO2026-07-29
00852421007850Pure&CleanPure & Clean, LLCFRO2026-07-29
04260056880667XPERIENCE Advanced Surgical IrrigationOSARTIS GmbHFRO2026-07-28
10841495149815QUIKCLOTTELEFLEX INCORPORATEDFRO2026-07-27
B665AC510011AC5 Advanced Wound SystemArch Therapeutics, Inc.FRO2026-07-24
B665AVX030011VIA LinxArch Therapeutics, Inc.FRO2026-07-24
00852421007300Pure&CleanPure & Clean, LLCFRO2026-07-22
00818582012867Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00818582012881Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002451Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002475Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
00852009002536Puracyn® Plus OTCInnovacyn, Inc.FRO2026-07-17
10197344169450MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-17
09551012610479ELECTROCYN somaV3BIO SDN. BHD.FRO2026-07-16
10197344176007MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176014MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176021MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
10197344176038MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-13
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