FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439603352
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOT11PCHKA
Catalog number
SOT11PCHKA
Device description
PCNL PACK
Published
2019-10-31
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
50888439603352PackageGS13In Commercial Distribution
10888439603354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843960335250888439603352
1088843960335410888439603354

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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

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Primary DI, Brand, Company table
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06925816667237ClearPetraWell Lead Medical Co.,LtdFGA2026-03-16
06925816657511ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
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06925816657580ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
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06925816657634ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
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06925816657658ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
06925816657665ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
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06925816657689ClearPetraWell Lead Medical Co.,LtdFGA2026-01-26
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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