FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956463066
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOP69SHMEP
Catalog number
SOP69SHMEP
Device description
SHOULDER ARTHROSCOPY PACK
Published
2026-06-01
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
50198956463064PackageGS12In Commercial Distribution
10198956463066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895646306450198956463064
1019895646306610198956463066

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic surgical procedure kit, medicatedA collection of various sterile surgical and endoscopic instruments, dressings, pharmaceuticals, and the necessary materials used to perform an arthroscopic surgical procedure. 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
50192253071595CONVERTORS8184NA8184NA2026-06-02
50192253071601CONVERTORS8187N8187N2026-06-02
50192253071618CONVERTORS8188NC8188NC2026-06-02
50192253071625CONVERTORS8189N8189N2026-06-02
20192253005971CONVERTORSAT7004AT70042019-04-16
20192253017080Kendall31.3876.0431.3876.042023-03-16
50885380183001CARDINAL HEALTH50001218500012182023-08-11
50885380182998CARDINAL HEALTH50001217500012172023-08-11
10197106817643CARDINAL HEALTHSEYHBDPANBSEYHBDPANB2026-06-01
10198956004887CARDINAL HEALTHSBAHFRPASCSBAHFRPASC2026-06-01
10198956201804CARDINAL HEALTH32-0828C32-0828C2026-06-01
10198956209220CARDINAL HEALTHPG33GLVWBPG33GLVWB2026-06-01
10198956225992CARDINAL HEALTHSOP54PPUOBSOP54PPUOB2026-06-01
10198956245754CARDINAL HEALTHSBACGKTACFSBACGKTACF2026-06-01
10198956248908CARDINAL HEALTHSAN43CATOBSAN43CATOB2026-06-01
10198956269323CARDINAL HEALTHSOP4QSHCLBSOP4QSHCLB2026-06-01
10198956311282CARDINAL HEALTHSCV11VSJKJSCV11VSJKJ2026-06-01
10198956312043CARDINAL HEALTHPW30PSPRHPW30PSPRH2026-06-01
10198956314634CARDINAL HEALTHSBAMIFPACBSBAMIFPACB2026-06-01
10198956314894CARDINAL HEALTHSEN42HNAMDSEN42HNAMD2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956225992CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956269323CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956321441CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956334670CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956360716CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956361461CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956372054CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956372498CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956378964CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956379176CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956388031CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956391253CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956392205CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956395206CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956396913CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956398511CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956409774CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956409880CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956421912CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956424166CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956427167CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956435506CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956437845CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956439184CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956440906CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956445659CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956457782CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956459922CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956463080CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01
10198956465657CARDINAL HEALTHCardinal Health 200, LLCOJH2026-06-01