FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956537279
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PL37CSSWJ
Catalog number
PL37CSSWJ
Device description
KIT, C SECTION
Published
2026-08-26
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
50198956537277PackageGS11In Commercial Distribution
10198956537279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895653727750198956537277
1019895653727910198956537279

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 Temperature00

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
10192253015553T.E.D.399539952026-06-19
20192253016748Kendall22853228532021-05-19
20192253016755Kendall2285522855-2021-02-23
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
20192253020240Kerlix332433242020-09-22
50192253020197Kerlix189218922020-08-12
50192253020357Kerlix673567352020-08-12
50192253020364Kerlix788278822020-08-12
50192253050422Devon31142931311429312023-07-10
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10198956537965CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-26
10198956563636CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-26
10198956524262CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-18
10198956556416CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-18
10198956554627CARDINAL HEALTHCardinal Health 200, LLCOHM2026-08-17
10198956510944CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-31
10198956516243CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-31
10198956538726CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-31
10198956542303CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-31
10198956360150CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956467965CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956481602CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956490017CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956508750CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956510067CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956519916CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956529274CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956531543CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956531918CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956533936CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956534179CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956534957CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956535381CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27
10198956536005CARDINAL HEALTHCardinal Health 200, LLCOHM2026-07-27