FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956591127
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBADHRPCME
Catalog number
SBADHRPCME
Device description
CMC ROBOTIC PACK
Published
2026-10-29
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
NWUEndoscope introducer kit

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956591125PackageGS12In Commercial Distribution
10198956591127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895659112550198956591125
1019895659112710198956591127

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

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
10192253069693Curity6309G6309G2026-10-29
10198956253209CARDINAL HEALTHSOTCGUPTRDSOTCGUPTRD2026-10-29
10198956323209CARDINAL HEALTHPGX4LTPREPGX4LTPRE2026-10-29
10198956359888CARDINAL HEALTHSOPOCHAWMCSOPOCHAWMC2026-10-29
10198956381759CARDINAL HEALTH34-6599D34-6599D2026-10-29
10198956423534CARDINAL HEALTHSAN11PD10BSAN11PD10B2026-10-29
10198956428195CARDINAL HEALTHPOV2CHCPUPOV2CHCPU2026-10-29
10198956435292CARDINAL HEALTH03-6720C03-6720C2026-10-29
10198956468184CARDINAL HEALTHSNE7CLMNHMSNE7CLMNHM2026-10-29
10198956485372CARDINAL HEALTHSMA23GLNIGSMA23GLNIG2026-10-29
10198956496101CARDINAL HEALTHSMA4EDCBDCSMA4EDCBDC2026-10-29
10198956503519CARDINAL HEALTHSBA4LGLGRFSBA4LGLGRF2026-10-29
10198956504745CARDINAL HEALTHSCV3MLVCVBSCV3MLVCVB2026-10-29
10198956513310CARDINAL HEALTHSOP23SACACSOP23SACAC2026-10-29
10198956517240CARDINAL HEALTHSOP31KAOSXSOP31KAOSX2026-10-29
10198956521032CARDINAL HEALTHSENCGTACPCSENCGTACPC2026-10-29
10198956531932CARDINAL HEALTHSBA8CBPSPBSBA8CBPSPB2026-10-29
10198956533592CARDINAL HEALTHSAN42PMTMPSAN42PMTMP2026-10-29
10198956533653CARDINAL HEALTHSCV4AAAJHVSCV4AAAJHV2026-10-29
10198956534490CARDINAL HEALTHPU13CPAJEPU13CPAJE2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956253209CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956552302CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956555693CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956558168CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956584013CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956598737CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956608481CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956608559CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
10198956620346CARDINAL HEALTHCardinal Health 200, LLCNWU2026-10-29
00677964154133Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154140Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154157Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154164Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154171Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154188Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154195Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154201Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154218Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154225Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154232Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154249Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154256Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154263Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154270Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154287Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154294Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154300Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154317Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154324Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28
00677964154331Endo Carry-on Procedure KitMEDIVATORS INC.NWU2026-10-28