FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106859902
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA57LLOH4
Catalog number
SBA57LLOH4
Device description
SOR LAPAROSCOPIC LITHOTOMY PK
Published
2024-12-04
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
OHDGynecological laparoscopic kit

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106859900PackageGS11In Commercial Distribution
10197106859902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710685990050197106859900
1019710685990210197106859902

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, non-medicated, single-useA collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS17800A0Aligned Medical SolutionsAligned Medical SolutionsOHD2026-07-21
10198956335486CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956412224CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956423169CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956458758CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956467705CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956469983CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956499225CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956507364CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956507746CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956516960CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956518575CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956521254CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956526259CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956526549CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956527034CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956527966CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956528550CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956529021CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956531901CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956532311CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956532458CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956532472CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956532625CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956533141CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956534391CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956535862CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-20
10198956444768CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-16
10198956453678CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-16
10198956458055CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-16