FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956463172
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOPHFOPESB
Catalog number
SOPHFOPESB
Device description
ORTHO PACK
Published
2026-07-27
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
50198956463170PackageGS15In Commercial Distribution
10198956463172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895646317050198956463170
1019895646317210198956463172

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

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
10192253072037CARDINAL HEALTHALMASK5ALMASK52026-07-29
10192253072044CARDINAL HEALTHAMMASK4AMMASK42026-07-29
10192253072051CARDINAL HEALTHAXLMASK6AXLMASK62026-07-29
10192253072068CARDINAL HEALTHCHIMASK3CHIMASK32026-07-29
10192253072075CARDINAL HEALTHINFMASK1INFMASK12026-07-29
10192253072082CARDINAL HEALTHNEOMASK0NEOMASK02026-07-29
10192253072105CARDINAL HEALTHTODMASK2TODMASK22026-07-29
10192253025699Dover888876051688887605162023-11-21
10192253025705Dover888876051888887605182023-11-21
10192253025712Dover888876052088887605202023-11-21
10192253025750Dover888876301888887630182023-11-21
10192253025774Dover888876302288887630222023-11-21
10192253026344Dover35603560-2022-04-12
10192253028201Dover62086208-2024-10-14
10192253030365Dover888849206688884920662025-04-07
10192253031836DoverP4P16ULDP4P16ULD-2024-08-22
10192253068573Dover33053305-2026-01-16
10192253068634Dover61556155-2026-01-16
10197106541029CARDINAL HEALTH01A1360C01A1360C2024-03-06
10197106741030CARDINAL HEALTH03-2242D03-2242D2024-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810135965088ToeJack Bunion Correction SystemNVision Biomedical Technologies, Inc.OJH2026-07-29
10809160527870HALYARDAVID MEDICAL, INC.OJH2026-07-28
10809160527979HALYARDAVID MEDICAL, INC.OJH2026-07-28
10198956301542CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956345898CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956354395CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956361652CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956362857CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956364431CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956365308CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956369122CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956371910CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956372467CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956377585CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956389564CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956390263CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956391192CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956392182CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956397323CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956406087CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956439405CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956446687CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956449541CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956451261CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956452732CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956453999CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956458369CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956461673CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956461833CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27
10198956467118CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-27