FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594775018
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP41THWF1
Catalog number
SOP41THWF1
Device description
TOTAL HIP PACK
Published
2022-08-04
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
OJHOrthopedic tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594775016PackageGS12In Commercial Distribution
10195594775018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559477501650195594775016
1019559477501810195594775018

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
B098AMS190580Aligned Medical SolutionsAligned Medical SolutionsOJH2026-07-12
10198956255586CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956334373CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956381773CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956393059CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956393103CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956397620CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956400665CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956401754CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956426344CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956442429CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956450806CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956462625CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956464810CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956468443CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956475908CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956477773CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956479586CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956480155CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956484290CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956489363CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956489974CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956492097CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956493506CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956494145CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956494381CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956497733CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956497801CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956499096CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09
10198956499799CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-09