FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956497634
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA45LAIMB
Catalog number
SBA45LAIMB
Device description
PACK HRH GYN LAPAROSCOPY
Published
2026-07-09
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
OHDGynecological laparoscopic kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHDGynecological Laparoscopic KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956497632PackageGS12In Commercial Distribution
10198956497634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895649763250198956497632
1019895649763410198956497634

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, medicatedA collection of various sterile surgical and endoscopic instruments (e.g., trocars, sleeves, cannulae), dressings, pharmaceuticals, and the necessary materials used to perform a laparoscopic 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
50885380213234Kendall3320533205B2026-10-28
50885380213241Kendall3320633206B2026-10-28
50885380213258Kendall3320733207B2026-10-28
10885380169922CARDINAL HEALTH212WPR212WPR2020-01-13
20884521100449Monoject8611U8611U2016-09-24
20884521100456Monoject8612U8612U2016-09-24
20192253024668Monoject888120201888812020182026-07-15
10192253040203Argyle1604091604092025-01-08
10192253040210Argyle43201432012025-01-08
10192253040241Argyle43308433082025-01-08
10192253040258Argyle43309433092025-01-08
10192253040265Argyle43311433112025-01-08
10192253040289Argyle888816011988881601192025-01-08
10192253040326Argyle888816040888881604082025-01-08
10192253040333Argyle888816042488881604242025-01-08
10192253040340Argyle888816043288881604322025-01-08
10192253040395Argyle888816083888881608382025-01-08
10192253040401Argyle888816085388881608532025-01-08
10192253046656Kendall55566BAMD55566BAMD2023-10-09
10195594567743CARDINAL HEALTHSBACNUBOL3SBACNUBOL32022-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956516342CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-26
10198956575028CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-26
10198956603493CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-26
10198956615564CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-26
10198956616578CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-26
10198956463417CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956584174CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956586437CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956586840CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956588653CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956589926CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956590878CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956595217CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956609754CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956612068CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-23
10198956414815CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956552289CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956558601CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956564800CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956576766CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956586581CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956586765CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956591103CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956594036CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956595064CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956607194CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956608221CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956609440CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-19
10198956577022CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-15
10198956573024CARDINAL HEALTHCardinal Health 200, LLCOHD2026-10-13