FDA.reportPublic FDA data

MEDLINE

Primary DI
10653160395416
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
ART1307
Catalog number
ART1307
Device description
18GX6" FEMORAL ART LINE KIT
Published
2026-10-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213481000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213481000Medline General Surgery TrayMedline Industries, Inc.2022-05-24LRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160395419PackageGS15In Commercial Distribution
10653160395416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160395419006531603954196531603954190653160395419
1065316039541610653160395416

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
true
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
10653160393894MEDLINEEBSI1883EBSI18832026-10-15
10653160394310MEDLINEEBSI1365BEBSI1365B2026-10-15
10653160394327MEDLINEDYNDV2345BDYNDV2345B2026-10-15
10653160394334MEDLINEDYNDV2720ADYNDV2720A2026-10-15
10653160394426MEDLINEEBSI1339CEBSI1339C2026-10-15
10653160394433MEDLINEEBSI1364BEBSI1364B2026-10-15
10653160394457MEDLINEEBSI1118BEBSI1118B2026-10-15
10653160394488MEDLINEDYNDV2796DYNDV27962026-10-15
10653160394556MEDLINEDYNDV2517ADYNDV2517A2026-10-15
10653160394587MEDLINEDYNDC3625DYNDC36252026-10-15
10653160394617MEDLINEDYNDH2389DYNDH23892026-10-15
10653160394662MEDLINEDYNDC3628DYNDC36282026-10-15
10653160394679MEDLINEDYNDC3627DYNDC36272026-10-15
10653160394693MEDLINEEBSI1567BEBSI1567B2026-10-15
10653160394877MEDLINEDYNDV2421ADYNDV2421A2026-10-15
10653160394907MEDLINEDYNDC3622ADYNDC3622A2026-10-15
10653160394969MEDLINEEBSI1147AEBSI1147A2026-10-15
10653160394983MEDLINEDYNDC3619DYNDC36192026-10-15
10653160395027MEDLINEEBSI1148AEBSI1148A2026-10-15
10653160395072MEDLINEDYNDV2812DYNDV28122026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956544017CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956549760CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956560765CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956566613CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956569966CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956575868CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956587267CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956590533CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956592476CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956598126CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956599550CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956601758CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956604209CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10198956606623CARDINAL HEALTHCardinal Health 200, LLCLRO2026-10-15
10653160394327MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394334MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394488MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394617MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394969MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160394983MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395027MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395171MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395188MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10653160395294MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-15
10809160540657HalyardAVID MEDICAL, INC.LRO2026-10-15
10885632540639SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-10-15
10885632540646SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-10-15
10653160395287MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-14
10653160395324MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-14
10653160395423MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-10-14