FDA.reportPublic FDA data

Medline

Primary DI
10080196915033
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJP1060A
Catalog number
DYNJP1060A
Device description
PACK,UNIVERSAL,SPLIT,AURORA
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYAGOWN, SURGICAL
KKKSUDAN IV
KKXDrape, surgical
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2
KKKSudan IvHematology1
KKXDrape, SurgicalGeneral, Plastic Surgery2
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196915034PackageGS14In Commercial Distribution
10080196915033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019691503440080196915034
1008019691503310080196915033

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The contents of this package may burn if exposed to a flame or extremely hot object. Avoid contact with an open flame or high intensity heat source.

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196321445MEDLINEMDS30804MDS308042026-09-24
30080196293548MEDLINENON28625NON286252026-09-24
40080196921554GeminiGEM5172GEM51722016-10-14
10197344175970MEDLINEESS7022EPESS7022EP2026-07-13
10080196632381MEDLINE INDUSTRIES, INC.MSC7344EPMSC7344EP2021-05-18
10193489104516MEDLINEMRPP2910MRPP29102024-07-11
10884389931943MEDLINE INDUSTRIES, INC.MSC7318EPMSC7318EP2021-05-18
10884389931950MEDLINE INDUSTRIES, INC.MSC7348EPMSC7348EP2021-05-18
20080196184085GeminiGEM3118SGEM3118S2016-10-14
20080196184283GeminiGEM3130SGEM3130S2016-10-14
20080196184344GeminiGEM3136SGEM3136S2016-10-14
20080196184498GeminiGEM3140SGEM3140S2016-10-14
20080196184559GeminiGEM3145SGEM3145S2016-10-14
20080196184610GeminiGEM3148SGEM3148S2016-10-14
20080196184696GeminiGEM3154SGEM3154S2016-10-14
20080196184986GeminiGEM4118SGEM4118S2020-12-22
20080196921185GeminiGEM1148GEM11482016-10-14
20080196921192GeminiGEM1154GEM11542016-10-14
20080196921307GeminiGEM3118GEM31182016-10-14
20080196921321GeminiGEM3124GEM31242016-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160535523HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-09-24
10885632538902SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-09-24
10198956273979CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956336667CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956373839CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956388338CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956426283CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956481978CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956495470CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956503700CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956521193CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956530669CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956532052CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956533905CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956547513CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956549555CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956550476CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956554108CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956555877CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956557024CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956557284CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956558427CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956559936CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956561809CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956562059CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956564589CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956565074CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956566163CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956568952CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956569683CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22