FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10195327160661
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ81187A
Catalog number
DYNJ81187A
Device description
PKY LAP LITH
Published
2022-05-22
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
FDElaparoscopy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDELaparoscopy KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327160662PackageGS12In Commercial Distribution
10195327160661PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532716066240195327160662
1019532716066110195327160661

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.

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196456765MEDLINEVDYND20302VDYND203022026-07-14
10080196031764MEDLINEDYND20125DYND201252026-07-13
10197344175963MEDLINEESS7012EPESS7012EP2026-07-13
10197344175970MEDLINEESS7022EPESS7022EP2026-07-13
10197344175987MEDLINEESS7044EPESS7044EP2026-07-13
10197344176007MEDLINEESS9022EPESS9022EP2026-07-13
10197344176014MEDLINEESS9045EPESS9045EP2026-07-13
10197344176021MEDLINEESS9048EPESS9048EP2026-07-13
10197344176038MEDLINEESS9066EPESS9066EP2026-07-13
10197344214723MEDLINEHCSLADYBUGSOLHCSLADYBUGSOL2026-07-13
20193489108214MEDLINEMDTZ1017073CAMDTZ1017073CA2026-07-13
20197344219435MEDLINEMDT2168056XGVMDT2168056XGV2026-07-13
20888277636559MEDLINEMDTZ1017073ABMDTZ1017073AB2026-07-13
10080196316809MedlineMSC8722EPMSC8722EP2023-08-15
10080196316816MedlineMSC8744EPMSC8744EP2023-08-15
10193489081053MedlineMSC8422MSC84222023-08-15
10193489081060MedlineMSC8444MSC84442023-08-15
10197344039821MEDLINEHNY19075HNY190752024-10-11
10884389122952MedlineMSC871X8EPMSC871X8EP2023-08-15
10884389155448MedlineMSC8488MSC84882023-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS184440Aligned Medical SolutionsAligned Medical SolutionsFDE2026-07-12
10198956395039CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956493599CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956509337CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956512672CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956514416CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956527041CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-09
10198956503618CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-06
B098AMS15230A0Aligned Medical SolutionsAligned Medical SolutionsFDE2026-06-25
10198956374119CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956387171CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956456778CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956488137CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956495968CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956496279CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956496620CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-08
10198956339392CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-05
10198956376748CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-05
10198956475502CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-05
10198956483743CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-05
10198956467675CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-03
10198956469280CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-03
10198956488656CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-03
10198956494459CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-03
10198956495500CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-03
10198956380455CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-01
10198956431935CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-01
10198956439580CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-01
10198956487208CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-01
10198956487826CARDINAL HEALTHCardinal Health 200, LLCFDE2026-06-01