FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10887488825106
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PUOCNYVBT
Catalog number
PUOCNYVBT
Device description
KIT,PERCUTANEOUS NEPHROSCOPY
Published
2017-11-28
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
FGAKit, nephroscope

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50887488825104PackageGS11In Commercial Distribution
10887488825106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748882510450887488825104
1088748882510610887488825106

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 Temperature040 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
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956101524CARDINAL HEALTHSOP73TKAPBSOP73TKAPB2026-06-03
10198956177055CARDINAL HEALTHPBCGPVWTIPBCGPVWTI2026-06-03
10198956198456CARDINAL HEALTHSMA69OMBFFSMA69OMBFF2026-06-03
10198956309012CARDINAL HEALTHMAT534227DMAT534227D2026-06-03
10198956320086CARDINAL HEALTHSOP73HESJESOP73HESJE2026-06-03
10198956320123CARDINAL HEALTHPV63ADSTIPV63ADSTI2026-06-03
10198956328938CARDINAL HEALTHSCV3ICVJCDSCV3ICVJCD2026-06-03
10198956332638CARDINAL HEALTHSOP52AC52ASOP52AC52A2026-06-03
10198956334915CARDINAL HEALTHSANCGCARIFSANCGCARIF2026-06-03
10198956346369CARDINAL HEALTHSCVCGEPSBBSCVCGEPSBB2026-06-03
10198956348950CARDINAL HEALTHSBA4LMNGRESBA4LMNGRE2026-06-03
10198956362147CARDINAL HEALTHSOP73KPIODSOP73KPIOD2026-06-03
10198956363922CARDINAL HEALTHSEN41FPVVDSEN41FPVVD2026-06-03
10198956371040CARDINAL HEALTHSOP56KAOSHSOP56KAOSH2026-06-03
10198956372641CARDINAL HEALTHSOP43ARANBSOP43ARANB2026-06-03
10198956379008CARDINAL HEALTHSOP45CAGHISOP45CAGHI2026-06-03
10198956385689CARDINAL HEALTHSOP44TKSVCSOP44TKSVC2026-06-03
10198956386099CARDINAL HEALTHSMA56IVRCBSMA56IVRCB2026-06-03
10198956390928CARDINAL HEALTHSBA54LCTCCSBA54LCTCC2026-06-03
10198956391437CARDINAL HEALTHSOT42SPMSESOT42SPMSE2026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810068811114MONARCH™ Mini-PCNL Suction SetAuris Health, Inc.FGA2026-05-05
06925816667213ClearPetraWell Lead Medical Co.,LtdFGA2026-03-16
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