FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439259384
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOTHFPUBM1
Catalog number
SOTHFPUBM1
Device description
PEDIATRIC UROLOGY WOLFSON PACK
Published
2018-11-19
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
NWUEndoscope introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWUEndoscope Introducer KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439259382PackageGS16In Commercial Distribution
10888439259384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843925938250888439259382
1088843925938410888439259384

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, medicated, single-useA collection of various sterile urological surgical instruments, dressings, pharmaceuticals, and the necessary materials intended to be used to perform a urological surgical procedure; is not dedicated to a specific type of urological surgical procedure. 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
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10885380058134CONVERTORSD1062D10622016-06-29
10885380058387CONVERTORS945094502016-06-28
10885380062278CONVERTORS944494442016-06-22
10885380062285CONVERTORS755475542016-06-28
10885380062308CONVERTORS955695562016-07-08
10885380063664CONVERTORS29452294522016-06-28
10885380071539CONVERTORS956295622016-07-13
10885380071652CONVERTORS29417294172016-06-28
10885380071690CONVERTORS29458294582016-06-28
10885380108624CONVERTORS29430294302016-06-22
10885380108648CONVERTORS29447294472016-06-22
10885380108655CONVERTORS29448294482016-06-22
10885380108662CONVERTORS29449294492016-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956482791CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-03
10198956332102CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956372610CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956388598CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956394643CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956397712CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956448278CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956464322CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956469020CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956475786CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956487369CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
10198956491571CARDINAL HEALTHCardinal Health 200, LLCNWU2026-06-01
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