FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594874667
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA35HSMO5
Catalog number
SMA35HSMO5
Device description
OPERATIVE HYSTEROSCOPY PACK
Published
2022-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRPTRAY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594874665PackageGS14In Commercial Distribution
10195594874667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559487466550195594874665
1019559487466710195594874667

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, medicatedA collection of various sterile surgical and endoscopic instruments (e.g., trocars, sleeves, cannulae), dressings, pharmaceuticals, and the necessary materials used to perform a laparoscopic surgical procedure. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661219527046DELACROIX-CHEVALIERLANDANGERLRP2026-07-12
10198956392977CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956449992CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956482401CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956499195CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956505513CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956507180CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956518438CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956518902CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956524934CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956524965CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956528772CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956528819CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956529137CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956531888CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956532519CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956532526CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956532892CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956380615CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956477384CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956497887CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956529175CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956529243CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
10198956529304CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-06
00190446917861Arsenal FootTrilliant Surgical, LLCLRP2026-06-25
00190446917878Arsenal FootTrilliant Surgical, LLCLRP2026-06-25
00190446934417Arsenal FootTrilliant Surgical, LLCLRP2026-06-25
00190446934424Arsenal FootTrilliant Surgical, LLCLRP2026-06-25
00190446934431Arsenal FootTrilliant Surgical, LLCLRP2026-06-25
00190446934448Arsenal FootTrilliant Surgical, LLCLRP2026-06-25