FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594550172
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT30HUPRA
Catalog number
SOT30HUPRA
Device description
HD UROLOGY PACK
Published
2022-05-26
Public version status
Update
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
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594550170PackageGS13In Commercial Distribution
10195594550172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559455017050195594550170
1019559455017210195594550172

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, non-medicated, single-useA collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device.

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
00884450485163Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-23
B098AMS191180Aligned Medical SolutionsAligned Medical SolutionsOEQ2026-07-22
00884450421581Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-21
10198956443013CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956462717CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956469075CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956488793CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956490192CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956493551CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956497207CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956499409CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956510715CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956514966CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956518605CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956520653CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956527355CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528543CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528567CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528635CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528802CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956528949CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956529731CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956530829CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956531185CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956531758CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956531895CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956532687CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956532731CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956532823CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20
10198956533479CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-20