FDA.reportPublic FDA data

Arthrex®

Primary DI
10888867346243
Brand
Arthrex®
Company
ARTHREX, INC.
Model
ABS-4060-10
Catalog number
ABS-4060-10
Device description
JumpStart FlexEFit (10 pack)
Published
2023-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
10888867346243PackageGS110In Commercial Distribution
00888867346246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088886734624310888867346243
00888867346246008888673462468888673462460888867346246

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
+1(800)934-4404complaints@arthrex.com

Regulatory Flags#

DUNS number
131747628
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888867304598Arthrex®AR-7285AR-72852026-07-08
00888867304604Arthrex®AR-7286AR-72862026-07-08
00888867304789Arthrex®AR-7285-1AR-7285-12026-07-08
00888867304796Arthrex®AR-7286-1AR-7286-12026-07-08
00888867023987Arthrex®AR-1934BFT-2AR-1934BFT-22019-03-09
00888867097216Arthrex®AR-1938PHSAR-1938PHS2017-05-11
00888867157767Arthrex®AR-1588TN-2AR-1588TN-22017-08-15
00888867178649Arthrex®AR-8827L-32SAR-8827L-32S2017-04-07
00888867178694Arthrex®AR-8827L-42SAR-8827L-42S2017-04-07
00888867178731Arthrex®AR-8827L-50SAR-8827L-50S2017-04-07
00888867178748Arthrex®AR-8827L-52SAR-8827L-52S2017-04-07
00888867178755Arthrex®AR-8827L-54SAR-8827L-54S2017-05-11
00888867178762Arthrex®AR-8827L-56SAR-8827L-56S2017-05-11
00888867178779Arthrex®AR-8827L-58SAR-8827L-58S2017-05-11
00888867179455Arthrex®AR-8835-65SAR-8835-65S2017-04-07
00888867179462Arthrex®AR-8835-70SAR-8835-70S2017-04-07
00888867179479Arthrex®AR-8835-75SAR-8835-75S2017-04-07
00888867179486Arthrex®AR-8835-80SAR-8835-80S2017-04-07
00888867196537Arthrex®AR-8943C-07SAR-8943C-07S2017-05-11
00888867196582Arthrex®AR-8943C-12SAR-8943C-12S2017-05-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850019138511SilverSealNEXGEL Inc.FRO2026-07-08
00850067990086Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990178Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990260Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990352Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990444Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990536Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990628Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990710Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990802Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
00850067990895Anexa BiomedicalANEXA BIOMEDICAL, INC.FRO2026-07-06
10884389161562MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-07-06
00361470000175Amerigel Saline Wound WashAmerx Health Care Corp.FRO2026-06-22
00050428280669CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-06-04
00050428453599CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-06-04
50192253067901ASOCardinal Health 200, LLCFRO2026-06-03
00714196111050DermaRite Medical DermaHoney Medical Grade Honey 0.5 oz TubeSion Brands LLCFRO2026-06-01
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01714196222045DermaRite Medical DermaHoney Tulle Non Border Honey Gauze 4x4Sion Brands LLCFRO2026-06-01
01714196333048DermaRite Medical DermaHoney Border Medical Grade Honey Sheet 4x4Sion Brands LLCFRO2026-06-01
08717249680130DermaRite Medical L-Mesitran 0.5 oz TubeSion Brands LLCFRO2026-06-01
08717249680147DermaRite Medical L-Mesitran 1.75 oz TubeSion Brands LLCFRO2026-06-01
00850087488259CeeportCEEPORT INC.FRO2026-05-29
00850087488266CeeportCEEPORT INC.FRO2026-05-29
10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415386MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27