FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594702946
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA57GYSA4
Catalog number
SMA57GYSA4
Device description
GYN LAPAROSCOPY PACK
Published
2022-05-31
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
50195594702944PackageGS12In Commercial Distribution
10195594702946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559470294450195594702944
1019559470294610195594702946

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. 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