FDA.reportPublic FDA data

Medline

Primary DI
10080196749317
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJP9070
Catalog number
DYNJP9070
Device description
PACK,LITHOTOMY,PK VIII
Published
2021-02-05
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
LROGeneral surgery tray

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196749318PackageGS110In Commercial Distribution
10080196749317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019674931840080196749318
1008019674931710080196749317

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). 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
Premarket 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
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
10888277720749MedlineMSC8722EPFMSC8722EPF2023-08-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160527016HalyardAVID MEDICAL, INC.LRO2026-07-13
10809160527023HalyardAVID MEDICAL, INC.LRO2026-07-13
B098AMS14885C0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS17983A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS18306A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS192890Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS192920Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
B098AMS8144C0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-12
10809160526989HalyardAVID MEDICAL, INC.LRO2026-07-10
10809160526996HalyardAVID MEDICAL, INC.LRO2026-07-10
10885632524950SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-07-10
10885632526978SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-07-10
10885632526992SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-07-10
10198956074668CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956119260CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956286719CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956386303CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956387959CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956420076CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956425996CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956457119CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956459878CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956462007CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956462151CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956473478CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956475427CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956483675CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956485068CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956490956CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09
10198956491496CARDINAL HEALTHCardinal Health 200, LLCLRO2026-07-09