FDA.report

CARDINAL HEALTH

Primary DI
50197106925957
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOPCNBKTE3
Catalog number
SOPCNBKTE3
Device description
BILATERAL KNEE PACK
Published
2025-02-04
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

Related Records

Product Codes

CodeName
OJHOrthopedic tray

Product Code Classifications

CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50197106925957PackageGS11In Commercial Distribution
10197106925959PrimaryGS10

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

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 DIBrandModelCatalogPublished
50198956219043CARDINAL HEALTHSBA29BRCCFSBA29BRCCF2026-03-24
50198956219401CARDINAL HEALTHSOT29UR87ESOT29UR87E2026-03-24
50198956220513CARDINAL HEALTHSOT29CPCCDSOT29CPCCD2026-03-24
50198956220643CARDINAL HEALTHSCV29MN87ESCV29MN87E2026-03-24
50198956278484CARDINAL HEALTHSOPCNPPRVCSOPCNPPRVC2026-03-24
50198956284980CARDINAL HEALTH34-8041H34-8041H2026-03-24
50198956285987CARDINAL HEALTHSBACNLSMBGSBACNLSMBG2026-03-24
50198956300116CARDINAL HEALTH17C4553C17C4553C2026-03-24
50198956300499CARDINAL HEALTHSAN12BSSUJSAN12BSSUJ2026-03-24
50198956302929CARDINAL HEALTHSOP32SHFLKSOP32SHFLK2026-03-24
50198956306866CARDINAL HEALTHSBAOCBLCPCSBAOCBLCPC2026-03-24
50198956307986CARDINAL HEALTHSOP21EPSCGSOP21EPSCG2026-03-24
50198956308006CARDINAL HEALTHSOP21KPSCJSOP21KPSCJ2026-03-24
50198956311372CARDINAL HEALTHPVCGCGAUFPVCGCGAUF2026-03-24
50198956314687CARDINAL HEALTHSMAHDGVAAGSMAHDGVAAG2026-03-24
50198956322897CARDINAL HEALTHSEN1DNSUNNSEN1DNSUNN2026-03-24
50198956327939CARDINAL HEALTHSBACGMPACFSBACGMPACF2026-03-24
50198956328851CARDINAL HEALTHSANCGRPILCSANCGRPILC2026-03-24
50198956334760CARDINAL HEALTHSBACGHERIFSBACGHERIF2026-03-24
50198956335569CARDINAL HEALTHSNE19NSKHRSNE19NSKHR2026-03-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00191072241979ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072241986ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072241993ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072242006ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072242013ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00191072242020ACSAMERICAN CONTRACT SYSTEMS, INC.OJH2026-03-24
00869397000013XL Instrument SetSi-Bone Inc.OJH2026-03-24
00869397000020Radiolucent Instrument SetSi-Bone Inc.OJH2026-03-24
00869397000037Standard Instrument SetSi-Bone Inc.OJH2026-03-24
00869397000044Removal System Instrument SetSi-Bone Inc.OJH2026-03-24
008693970000517.5mm & 10.75mm Instrument SetSi-Bone Inc.OJH2026-03-24
50198956278484CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956302929CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956307986CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956308006CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956357981CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956360530CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
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50198956415186CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956425697CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956426397CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956426762CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956427394CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24
50198956429312CARDINAL HEALTHCardinal Health 200, LLCOJH2026-03-24