FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439373798
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA18GLBH3
Catalog number
SMA18GLBH3
Device description
CUSTOM GYN LAPAROSCSOPY NWK
Published
2019-02-19
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
OHDGynecological laparoscopic kit

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439373798PackageGS16In Commercial Distribution
10888439373790PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843937379850888439373798
1088843937379010888439373790

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, medicatedA collection of various sterile surgical and endoscopic instruments (e.g., trocars, sleeves, cannulae), dressings, pharmaceuticals, and the necessary materials used to perform a laparoscopic 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
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