FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10885425793518
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA13RBDHB
Catalog number
SMA13RBDHB
Device description
LAPAROSCOPY GU GYN ROBOTICS PK
Published
2016-06-27
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
OHDGynecological laparoscopic kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHDGynecological Laparoscopic KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885425793516PackageGS12In Commercial Distribution
10885425793518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088542579351650885425793516
1088542579351810885425793518

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, non-medicated, single-useA collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a single-use device.

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
Primary DIBrandModelCatalogPublished
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956313576CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956333888CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956428003CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956467446CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956484467CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956485150CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956492349CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956497634CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956497672CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956504950CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956505773CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956509290CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956515543CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956525054CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956527423CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956528079CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-09
10198956477001CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956505612CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956509344CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956525184CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956526747CARDINAL HEALTHCardinal Health 200, LLCOHD2026-07-06
10198956318595CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-23
10198956488496CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-23
10198956510227CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-23
10198956511088CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-23
10198956515253CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-23
10198956436626CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956465176CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956467651CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08
10198956488922CARDINAL HEALTHCardinal Health 200, LLCOHD2026-06-08