FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594703431
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA23CS165
Catalog number
SMA23CS165
Device description
C SECTION PACK
Published
2022-06-06
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
50195594703439PackageGS12In Commercial Distribution
10195594703431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559470343950195594703439
1019559470343110195594703431

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.

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
10192253004205Monoject1525SA1525SA2026-07-13
10192253004410Monoject8507MW8507MW2026-07-13
10192253004540Monoject8533SA8533SA2026-07-13
10192253004588Monoject8537MW8537MW2026-07-13
10192253004625SharpSafety8540SA8540SA2026-07-13
10192253004885Monoject8900MW8900MW2026-07-13
10192253005127Monoject8979MW8979MW2026-07-13
10192253005509Monoject8525Y8525Y2026-07-13
10192253071894Argyle47802478022026-07-13
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956482203CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956495234CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956497832CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956498129CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956499249CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956231061CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956453227CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956466029CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956487239CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956489370CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956491984CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956493964CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956496323CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956467378CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-03
10198956488120CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-03