FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439467886
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA54CEMTB
Catalog number
SMA54CEMTB
Device description
C SECTION PACK MOUNTAIN VISTA
Published
2019-06-21
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
OHMCesarean section tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHMCesarean Section TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439467886PackageGS12In Commercial Distribution
10888439467888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843946788650888439467886
1088843946788810888439467888

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

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
10198956428201CARDINAL HEALTH26-2755C26-2755C2026-10-01
10198956512474CARDINAL HEALTH28A5420I28A5420I2026-10-01
10198956524316CARDINAL HEALTH34A5387R34A5387R2026-10-01
10198956537385CARDINAL HEALTH28-6325B28-6325B2026-10-01
10198956563087CARDINAL HEALTH34-2454E34-2454E2026-10-01
10198956587298CARDINAL HEALTH40-6487C40-6487C2026-10-01
10885380214714Curity8441368441362026-09-30
10885380214738Curity8441568441562026-09-30
10885380214707Curity8441268441262026-09-28
10885380214721Curity8441468441462026-09-28
10885380214745Curity8441668441662026-09-28
10885380214752Curity8441768441762026-09-28
10885380214769Curity8442168442162026-09-28
10885380214776Curity8442268442262026-09-28
10885380214783Curity8442368442362026-09-28
10885380214790Curity8442468442462026-09-28
10885380214806Curity8442568442562026-09-28
20192253017561Medi-Trace Cadence22660P22660P2024-02-28
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
50885380050365CARDINAL HEALTHCA901CHCA901CH2021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956558328CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-30
10198956591769CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-30
10198956596368CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-30
10198956598423CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-30
10198956450684CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956519022CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956557574CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956568136CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956572041CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956580848CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956586000CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956589186CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-25
10198956271418CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956576902CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956580596CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956584587CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956584600CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956587090CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-22
10198956450417CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-21
10809160538364HalyardMEDICAL ACTION INDUSTRIES INC.OHM2026-09-21
10198956514461CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956556676CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956562288CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956570221CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956570412CARDINAL HEALTHCardinal Health 200, LLCOHM2026-09-04
10198956499720CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-26
10198956537279CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-26
10198956537965CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-26
10198956563636CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-26
10198956524262CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-18