FDA.reportPublic FDA data

Procellera FLexEFit

Primary DI
00810198031140
Brand
Procellera FLexEFit
Company
ARTHREX, INC.
Model
"2.5""x6.3"""
Catalog number
VFC-2563
Device description
"Procellera FLexEFit OTC, 2.5""x6.3"""
Published
2022-11-18
Public version status
Update
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
K180533000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180533000Procellera Composite Antibacterial Wound DressingVomaris Wound Care, Inc.2018-12-10FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810198031140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810198031140008101980311408101980311400810198031140

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectric wound dressingA sterile wound covering containing microcell batteries [e.g., based on silver (Ag)/zinc(Zn)] designed to mimic a physiologic electric field in the presence of a conductive medium (e.g. saline, hydrogel, or wound exudate) to destroy microbial pathogens (antimicrobial) at the dressing surface and help reduce the risk of wound infection. It is intended to cover partial- and full-thickness wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and help create a moist wound-healing environment. It is in the form of a flat sheet/pad, may be designed to absorb wound exudates, but does not have wound-nonadherent properties. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(480) 921-4948customerservice@vomaris.com

Regulatory Flags#

DUNS number
131747628
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867498105Arthrex®AR-3210-0037AR-3210-00372026-07-31
00888867532236Arthrex®AR-S7500-030-260-SAR-S7500-030-260-S2026-07-31
00888867532243Arthrex®AR-S7500-030-360-SAR-S7500-030-360-S2026-07-31
00888867532250Arthrex®AR-S7500-040-260-SAR-S7500-040-260-S2026-07-31
00888867532267Arthrex®AR-S7500-040-360-SAR-S7500-040-360-S2026-07-31
00888867532274Arthrex®AR-S7500-050-260-SAR-S7500-050-260-S2026-07-31
00888867544819Arthrex®AR-S7510-030-260AR-S7510-030-2602026-07-31
00888867544826Arthrex®AR-S7510-040-260AR-S7510-040-2602026-07-31
00888867544833Arthrex®AR-S7510-050-260AR-S7510-050-2602026-07-31
00888867544840Arthrex®AR-S7563-030-260AR-S7563-030-2602026-07-31
00888867544857Arthrex®AR-S7563-030-360AR-S7563-030-3602026-07-31
00888867544864Arthrex®AR-S7570-030-260AR-S7570-030-2602026-07-31
00888867544871Arthrex®AR-S7570-030-360AR-S7570-030-3602026-07-31
00888867544888Arthrex®AR-S7570-040-260AR-S7570-040-2602026-07-31
00888867544895Arthrex®AR-S7570-040-360AR-S7570-040-3602026-07-31
00888867572010Arthrex®AR-S7500-000-000WAR-S7500-000-000W2026-07-31
00888867572034Arthrex®AR-S7500-100-000WAR-S7500-100-000W2026-07-31
00888867572041Arthrex®AR-S7500-100-000FAR-S7500-100-000F2026-07-31
00888867571129Arthrex®ABS-1981-20SABS-1981-20S2026-07-29
00888867020498Arthrex®AR-1648AR-16482018-08-03

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00818582013796Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
00818582013802Puracyn® Plus Professional FormulaInnovacyn, Inc.FRO2026-07-31
10197344169405MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-31
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