FDA.reportPublic FDA data

MEDLINE INDUSTRIES, INC.

Primary DI
10198459487996
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ911121A
Catalog number
DYNJ911121A
Device description
CYSTO CDS
Published
2025-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
40198459487997PackageGS14In Commercial Distribution
10198459487996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019845948799740198459487997
1019845948799610198459487996

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
10193489086331MEDLINEMDS9082111MDS90821112026-08-27
10197344011858HUDSON RCIHUD1695HUD16952026-08-27
10197344011865HUDSON RCIHUD1694HUD16942026-08-27
10197344011872HUDSON RCIHUD1693HUD16932026-08-27
10197344011889HUDSON RCIHUD1692HUD16922026-08-27
10197344011896HUDSON RCIHUD1691HUD16912026-08-27
10197344011902HUDSON RCIHUD1690HUD16902026-08-27
10197344011919HUDSON RCIHUD1689HUD16892026-08-27
10197344011926HUDSON RCIHUD1688HUD16882026-08-27
10197344011933HUDSON RCIHUD1687HUD16872026-08-27
10197344011940HUDSON RCIHUD1686HUD16862026-08-27
10197344011957HUDSON RCIHUD1685HUD16852026-08-27
10197344011964HUDSON RCIHUD1683HUD16832026-08-27
10197344016884HUDSON RCIHUD2701LHUD2701L2026-08-27
10197344016891HUDSON RCIHUD2701MHUD2701M2026-08-27
10197344016938HUDSON RCIHUD2701SHUD2701S2026-08-27
10197344016945HUDSON RCIHUD2701XLHUD2701XL2026-08-27
10197344016969HUDSON RCIHUD2702HUD27022026-08-27
10197344016976HUDSON RCIHUD2703HUD27032026-08-27
10197344016983HUDSON RCIHUD2704HUD27042026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956330221CARDINAL HEALTHCardinal Health 200, LLCFDE2026-08-26
10198956547742CARDINAL HEALTHCardinal Health 200, LLCFDE2026-08-26
10198956564473CARDINAL HEALTHCardinal Health 200, LLCFDE2026-08-26
10198956556805CARDINAL HEALTHCardinal Health 200, LLCFDE2026-08-18
10198956515871CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10198956524354CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10198956530805CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10198956534421CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10198956538573CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-31
10809160527931HALYARDAVID MEDICAL, INC.FDE2026-07-28
10198956218109CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956360457CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956378339CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956429949CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956460652CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956462991CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956512351CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956516830CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956519619CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956523296CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956528710CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
10198956533332CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-27
B098AMS187280Aligned Medical SolutionsAligned Medical SolutionsFDE2026-07-22
10198956388888CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956494701CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956515680CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956516939CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956521681CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956532588CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-20
10198956458987CARDINAL HEALTHCardinal Health 200, LLCFDE2026-07-16