FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594661687
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA23DCCW4
Catalog number
SMA23DCCW4
Device description
D AND C PACK
Published
2022-05-03
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
PKFD and C tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKFD And C TrayUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594661685PackageGS12In Commercial Distribution
10195594661687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559466168550195594661685
1019559466168710195594661687

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.

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
10198956527799CARDINAL HEALTHCardinal Health 200, LLCPKF2026-07-09
10198956423077CARDINAL HEALTHCardinal Health 200, LLCPKF2026-07-06
10198956490949CARDINAL HEALTHCardinal Health 200, LLCPKF2026-07-06
10198956491823CARDINAL HEALTHCardinal Health 200, LLCPKF2026-07-06
10198956497658CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-08
10198956442467CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-05
10198956482302CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-05
10198956490536CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-05
10198956487567CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-01
10198956488502CARDINAL HEALTHCardinal Health 200, LLCPKF2026-06-01
10195594785321CARDINAL HEALTHCardinal Health 200, LLCPKF2022-10-27
10195594804152CARDINAL HEALTHCardinal Health 200, LLCPKF2022-10-06
10195594847876CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-29
10195594808365CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-26
10195594830144CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-26
10195594837433CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-20
10195594827236CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-14
10195594714628CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-09
10195594813642CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-08
10195594821906CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-08
10195594825508CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-08
10195594809140CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-06
10195594814847CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-06
10195594803599CARDINAL HEALTHCardinal Health 200, LLCPKF2022-09-02
10195594790059CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-29
10195594783594CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-26
10195594789336CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-19
10195594790950CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-19
10195594792329CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-19
10195594781392CARDINAL HEALTHCardinal Health 200, LLCPKF2022-08-17