FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439694473
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT11PCHK1
Catalog number
SOT11PCHK1
Device description
PCNL PACK
Published
2020-01-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGAKit, nephroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGAKit, NephroscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439694473PackageGS13In Commercial Distribution
10888439694475PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843969447350888439694473
1088843969447510888439694475

GMDN Terms#

Term, Definition table
TermDefinition
Nephroscopic surgical procedure kit, medicatedA collection of various sterile surgical and endoscopic instruments, dressings, pharmaceuticals, and the necessary materials used to perform a nephroscopic surgical procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810068811114MONARCH™ Mini-PCNL Suction SetAuris Health, Inc.FGA2026-05-05
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06925816667220ClearPetraWell Lead Medical Co.,LtdFGA2026-03-16
06925816667237ClearPetraWell Lead Medical Co.,LtdFGA2026-03-16
06925816657511ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657528ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657535ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657542ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657559ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657566ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657573ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657580ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657597ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657603ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657610ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657627ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657634ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657641ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657658ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657665ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657672ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657689ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657696ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657702ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657719ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657726ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657733ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657740ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
00810143891294Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FGA2025-04-25
04055207038666NARichard Wolf GmbHFGA2024-04-01