FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106748596
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT73CTCPA
Catalog number
SOT73CTCPA
Device description
CYSTO TURP PACK
Published
2024-09-11
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
NWAProsthesis, tracheal, preformed/molded

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWAProsthesis, Tracheal, Preformed/MoldedGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106748594PackageGS12In Commercial Distribution
10197106748596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710674859450197106748594
1019710674859610197106748596

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.

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
10192253004489SharpSafety85221852212026-09-24
10192253004502Monoject8522Y8522Y2026-09-24
10192253004557Monoject8533Y8533Y2026-09-24
10192253004571Monoject8536SA8536SA2026-09-24
10192253004632SharpSafety8541SA8541SA2026-09-24
10192253005059Monoject89651896512026-09-24
10192253005080Monoject8967Y8967Y2026-09-24
10192253005493Monoject8506Y8506Y2026-09-24
20885380075169CARDINAL HEALTHUSA-N95-SUSA-N95-S2016-08-02
20885380075183CARDINAL HEALTHUSA-N95-RUSA-N95-R2016-08-02
10198956271418CARDINAL HEALTHSMADKCSOGDSMADKCSOGD2026-09-22
10198956273979CARDINAL HEALTHSNE41APFMASNE41APFMA2026-09-22
10198956313897CARDINAL HEALTHSNE69CRWHESNE69CRWHE2026-09-22
10198956320598CARDINAL HEALTH28-1807Z28-1807Z2026-09-22
10198956333758CARDINAL HEALTHSMA73GLKCHSMA73GLKCH2026-09-22
10198956336667CARDINAL HEALTHSBA57PIOHQSBA57PIOHQ2026-09-22
10198956338661CARDINAL HEALTH08-8060I08-8060I2026-09-22
10198956339255CARDINAL HEALTHSAN23CCPRFSAN23CCPRF2026-09-22
10198956346222CARDINAL HEALTHSMAHDRLAGBSMAHDRLAGB2026-09-22
10198956350434CARDINAL HEALTHPE23THMEHPE23THMEH2026-09-22

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Primary DI, Brand, Company table
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