FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106743582
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA69MAMVA
Catalog number
SBA69MAMVA
Device description
MAJOR LITHOTOMY PACK
Published
2024-09-09
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
LAAHigh pressure liquid chromatography, benzodiazepine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LAAHigh Pressure Liquid Chromatography, BenzodiazepineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106743582PackageGS12In Commercial Distribution
10197106743584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710674358250197106743582
1019710674358410197106743584

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.

Sterilization Methods#

Method table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106831021CARDINAL HEALTHCardinal Health 200, LLCLAA2024-12-31
50197106831029CARDINAL HEALTHCardinal Health 200, LLCLAA2024-12-31
10197106819371CARDINAL HEALTHCardinal Health 200, LLCLAA2024-12-12
50197106819379CARDINAL HEALTHCardinal Health 200, LLCLAA2024-12-12
10197106873083CARDINAL HEALTHCardinal Health 200, LLCLAA2024-12-11
50197106873081CARDINAL HEALTHCardinal Health 200, LLCLAA2024-12-11
10197106782743CARDINAL HEALTHCardinal Health 200, LLCLAA2024-10-25
50197106782741CARDINAL HEALTHCardinal Health 200, LLCLAA2024-10-25
10197106782132CARDINAL HEALTHCardinal Health 200, LLCLAA2024-09-25
10197106792957CARDINAL HEALTHCardinal Health 200, LLCLAA2024-09-25
50197106782130CARDINAL HEALTHCardinal Health 200, LLCLAA2024-09-25
50197106792955CARDINAL HEALTHCardinal Health 200, LLCLAA2024-09-25
10197106743584CARDINAL HEALTHCardinal Health 200, LLCLAA2024-09-09
10197106616956CARDINAL HEALTHCardinal Health 200, LLCLAA2024-08-30
50197106616954CARDINAL HEALTHCardinal Health 200, LLCLAA2024-08-30
10197106669815CARDINAL HEALTHCardinal Health 200, LLCLAA2024-07-03
50197106669813CARDINAL HEALTHCardinal Health 200, LLCLAA2024-07-03
10197106668979CARDINAL HEALTHCardinal Health 200, LLCLAA2024-06-26
50197106668977CARDINAL HEALTHCardinal Health 200, LLCLAA2024-06-26
10197106652381CARDINAL HEALTHCardinal Health 200, LLCLAA2024-06-05
50197106652389CARDINAL HEALTHCardinal Health 200, LLCLAA2024-06-05
10197106600436CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-24
10197106650110CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-24
50197106600434CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-24
50197106650118CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-24
10197106577974CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-19
10197106621868CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-19
50197106577972CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-19
50197106621866CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-19
10197106639214CARDINAL HEALTHCardinal Health 200, LLCLAA2024-04-17