FDA.report

CARDINAL HEALTH

Primary DI
50197106620128
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA4JLPUNB
Catalog number
SBA4JLPUNB
Device description
PK INST LAP CHOLE UN UW AN
Published
2024-05-16
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
PXVGeneral purpose instrument tray

Product Code Classifications

CodeDeviceSpecialtyClass
PXVGeneral Purpose Instrument TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50197106620128PackageGS12In Commercial Distribution
10197106620120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019710662012850197106620128
1019710662012010197106620120

GMDN Terms

TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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.

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

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10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
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10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956281668CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-19
50198956244588CARDINAL HEALTHCardinal Health 200, LLCPXV2025-12-09
50198956137477CARDINAL HEALTHCardinal Health 200, LLCPXV2025-08-05
50198956057508CARDINAL HEALTHCardinal Health 200, LLCPXV2025-06-05
90843356102744CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102751CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102768CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102775CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102782CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
90843356102799CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-11-20
50197106773282CARDINAL HEALTHCardinal Health 200, LLCPXV2024-10-23
00843356102819CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-08-19
00843356102826CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-08-19
00843356102833CYGNUSCYGNUS MEDICAL L.L.C.PXV2024-08-19
00811687031962MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032440MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032457MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032464MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032471MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00811687032815MCI - Medical Concept Innovation, Inc.MCI-MEDICAL CONCEPT INNOVATION INCPXV2024-08-08
00840183500016BR Surgical, LLCBR Surgical, LLCPXV2024-07-23
00840183515256BR Surgical, LLCBR Surgical, LLCPXV2024-07-23
00840183515270BR Surgical, LLCBR Surgical, LLCPXV2024-07-23
00840183518127BR Surgical, LLCBR Surgical, LLCPXV2024-07-23
00840183518158BR Surgical, LLCBR Surgical, LLCPXV2024-07-23
00840183518165BR Surgical, LLCBR Surgical, LLCPXV2024-07-23
00840183505400BR Surgical, LLCBR Surgical, LLCPXV2024-07-19
00840183504977BR Surgical, LLCBR Surgical, LLCPXV2024-07-18
50197106527373CARDINAL HEALTHCardinal Health 200, LLCPXV2024-02-08
50197106471232CARDINAL HEALTHCardinal Health 200, LLCPXV2023-12-01