FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956492899
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP33BPOB5
Catalog number
SOP33BPOB5
Device description
BASIC ORTHO PACK
Published
2026-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
50198956492897PackageGS12In Commercial Distribution
10198956492899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895649289750198956492897
1019895649289910198956492899

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, medicatedA collection of various sterile orthopaedic surgical instruments, dressings, and the necessary materials, which includes a pharmaceutical(s) intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956101524CARDINAL HEALTHSOP73TKAPBSOP73TKAPB2026-06-03
10198956177055CARDINAL HEALTHPBCGPVWTIPBCGPVWTI2026-06-03
10198956198456CARDINAL HEALTHSMA69OMBFFSMA69OMBFF2026-06-03
10198956309012CARDINAL HEALTHMAT534227DMAT534227D2026-06-03
10198956320086CARDINAL HEALTHSOP73HESJESOP73HESJE2026-06-03
10198956320123CARDINAL HEALTHPV63ADSTIPV63ADSTI2026-06-03
10198956328938CARDINAL HEALTHSCV3ICVJCDSCV3ICVJCD2026-06-03
10198956332638CARDINAL HEALTHSOP52AC52ASOP52AC52A2026-06-03
10198956334915CARDINAL HEALTHSANCGCARIFSANCGCARIF2026-06-03
10198956346369CARDINAL HEALTHSCVCGEPSBBSCVCGEPSBB2026-06-03
10198956348950CARDINAL HEALTHSBA4LMNGRESBA4LMNGRE2026-06-03
10198956362147CARDINAL HEALTHSOP73KPIODSOP73KPIOD2026-06-03
10198956363922CARDINAL HEALTHSEN41FPVVDSEN41FPVVD2026-06-03
10198956371040CARDINAL HEALTHSOP56KAOSHSOP56KAOSH2026-06-03
10198956372641CARDINAL HEALTHSOP43ARANBSOP43ARANB2026-06-03
10198956379008CARDINAL HEALTHSOP45CAGHISOP45CAGHI2026-06-03
10198956385689CARDINAL HEALTHSOP44TKSVCSOP44TKSVC2026-06-03
10198956386099CARDINAL HEALTHSMA56IVRCBSMA56IVRCB2026-06-03
10198956390928CARDINAL HEALTHSBA54LCTCCSBA54LCTCC2026-06-03
10198956391437CARDINAL HEALTHSOT42SPMSESOT42SPMSE2026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956101524CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956320086CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956332638CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956362147CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956371040CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956372641CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956379008CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956385689CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956391604CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956423756CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956447974CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956462243CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956464957CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956465756CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956467330CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956472785CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956478329CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956479630CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956481718CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956487529CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956488588CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956489981CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956490079CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956490185CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956490741CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956491007CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956491144CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956492523CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956492639CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03
10198956493209CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-03