FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106716618
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOTDHDRW20
Catalog number
SOTDHDRW20
Device description
DAVINCI ROBOT UROLOGY PACK
Published
2024-07-12
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
50197106716616PackageGS11In Commercial Distribution
10197106716618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710671661650197106716616
1019710671661810197106716618

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 Temperature040 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
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528334HALYARDAVID MEDICAL, INC.OHD2026-08-01
10198956368125CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956393295CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956460669CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956475281CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956500174CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956503052CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956505322CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956513822CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956516823CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956523326CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956538481CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956538580CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956543027CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-31
10198956196261CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956385573CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956392410CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956446632CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956448186CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956460676CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956469242CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956475182CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956485297CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956497726CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956502727CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956505926CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956507173CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956513044CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956513983CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27
10198956516267CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-27