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
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11
10812564036381MedlineSYN3872SYN38722026-03-11
10884389001677Teleflex/Hudson RCI540154012016-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160522332HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522349HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522356HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522363HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522370HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522394HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522400HalyardAVID MEDICAL, INC.LRO2026-06-02
10809160522448HalyardAVID MEDICAL, INC.LRO2026-06-02
10198956004887CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956245754CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956248908CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956312043CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956314634CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956314894CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956321717CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956356184CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956370760CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956376793CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956377363CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956384750CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956384873CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956385078CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956385160CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956391970CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956406193CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956439399CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956440685CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956444065CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956444850CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01
10198956445833CARDINAL HEALTHCardinal Health 200, LLCLRO2026-06-01