FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106298473
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBAHFSPCCA
Catalog number
SBAHFSPCCA
Device description
SET UP PACK
Published
2023-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PXNBasic set-up tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PXNBasic Set-Up TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106298471PackageGS18In Commercial Distribution
10197106298473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710629847150197106298471
1019710629847310197106298473

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956011175CARDINAL HEALTHCardinal Health 200, LLCPXN2025-04-17
50198956011173CARDINAL HEALTHCardinal Health 200, LLCPXN2025-04-17
10197106955222CARDINAL HEALTHCardinal Health 200, LLCPXN2025-03-25
50197106955220CARDINAL HEALTHCardinal Health 200, LLCPXN2025-03-25
10304040166618Henry ScheinHENRY SCHEIN, INC.PXN2023-07-30
10304040167707Henry ScheinHENRY SCHEIN, INC.PXN2023-07-30
10304040167899Henry ScheinHENRY SCHEIN, INC.PXN2023-07-30
00304040166611Henry ScheinHENRY SCHEIN, INC.PXN2023-07-30
00304040167700Henry ScheinHENRY SCHEIN, INC.PXN2023-07-30
00304040167892Henry ScheinHENRY SCHEIN, INC.PXN2023-07-30
50197106298471CARDINAL HEALTHCardinal Health 200, LLCPXN2023-07-11
00191375051374ENDOSKELETON®TITAN SPINE, LLCPXN2020-02-17
00191375051381ENDOSKELETON®TITAN SPINE, LLCPXN2020-02-17
00191375051398ENDOSKELETON®TITAN SPINE, LLCPXN2020-02-17
00191375051411ENDOSKELETON®TITAN SPINE, LLCPXN2020-02-17
00191375051428ENDOSKELETON®TITAN SPINE, LLCPXN2020-02-17
00191375051480ENDOSKELETON®TITAN SPINE, LLCPXN2020-02-17
00191375051749ENDOSKELETON®TITAN SPINE, LLCPXN2020-02-17
00191375051756ENDOSKELETON®TITAN SPINE, LLCPXN2020-02-17
00191375051763ENDOSKELETON®TITAN SPINE, LLCPXN2020-02-17
00191375052838ENDOSKELETON® TATITAN SPINE, LLCPXN2020-02-17
00191375052845ENDOSKELETON® TATITAN SPINE, LLCPXN2020-02-17
07613327419023Pivot GuardianSTRYKER CORPORATIONPXN2018-12-07
07613327419030Pivot GuardianSTRYKER CORPORATIONPXN2018-12-07
07613327419047Pivot GuardianSTRYKER CORPORATIONPXN2018-12-07
37613327419024Pivot GuardianSTRYKER CORPORATIONPXN2018-12-07
37613327419031Pivot GuardianSTRYKER CORPORATIONPXN2018-12-07
37613327419048Pivot GuardianSTRYKER CORPORATIONPXN2018-12-07