FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106166208
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA53CSLC2
Catalog number
SMA53CSLC2
Device description
C SECTION PACK
Published
2023-03-17
Public version status
New
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
OHMCesarean section tray

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106166206PackageGS11In Commercial Distribution
10197106166208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710616620650197106166206
1019710616620810197106166208

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, medicatedA collection of various sterile surgical instruments, dressings, pharmaceuticals, and materials intended to be used during obstetrical/gynaecological surgery; it is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253067958Dover200620062026-01-15
10192253067965Dover61536153-2026-01-15
10192253067972Dover61546154-2026-01-15
10192253067989Dover812281222026-01-15
10192253067996Dover888760078488876007842026-01-15
10192253068009Dover89498949-2026-01-15
10192253068016Dover895089502026-01-15
10192253068702Dover888760077688876007762026-01-16
10192253071405CARDINAL HEALTHALMASK5ALMASK52026-04-06
10192253071412CARDINAL HEALTHAMMASK4AMMASK42026-03-23
10192253071429CARDINAL HEALTHAXLMASK6AXLMASK62026-03-23
10192253071436CARDINAL HEALTHCHIMASK3CHIMASK32026-03-23
10192253071443CARDINAL HEALTHINFMASK1INFMASK12026-03-23
10192253071450CARDINAL HEALTHNEOMASK0NEOMASK02026-03-23
10192253071467CARDINAL HEALTHTODMASK2TODMASK22026-03-23
10192253006278Genius3030963030962024-02-28
10192253006285Genius3030973030972024-02-28
10192253047486Telfa766776672025-09-08
10197106917619CARDINAL HEALTHPC15OT92CPC15OT92C2026-07-20
10198956119505CARDINAL HEALTHSVA35VCBLCSVA35VCBLC2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956406162CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956454446CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956490994CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956491694CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956502086CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956505216CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956506510CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956512245CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956512986CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956532212CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956532540CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-20
10198956445048CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-16
10198956496422CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-16
10198956506442CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-16
10198956529038CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-16
10198956268272CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956460423CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956478985CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956485082CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956491243CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956497603CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956509870CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956519060CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956527508CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956528116CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-09
10198956487079CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-06
10198956526044CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-06
10198956493780CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-23
10198956515154CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-23
10198956312920CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08