FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956558434
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA45VYIMC
Catalog number
SMA45VYIMC
Device description
PACK SJB VAG HYST
Published
2026-09-29
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
OJFHysterectomy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJFHysterectomy KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956558432PackageGS12In Commercial Distribution
10198956558434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895655843250198956558432
1019895655843410198956558434

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgical procedure kit, medicatedA collection of various sterile surgical and endoscopic instruments (e.g., trocars, sleeves, cannulae), dressings, pharmaceuticals, and the necessary materials used to perform a laparoscopic surgical 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
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
10198956570924CARDINAL HEALTHCardinal Health 200, LLCOJF2026-09-30
10198956544451CARDINAL HEALTHCardinal Health 200, LLCOJF2026-08-17
10198956342217CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-31
10197106886960CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-27
10198956491090CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-27
10198956535374CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-27
10198956536647CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-27
10198956423046CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-20
10198956492127CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-20
10198956515468CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-20
10198956520288CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-20
10198956492103CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-09
10198956492363CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-09
10198956496330CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-09
10198956498389CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-06
10198956525504CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-06
10198956526020CARDINAL HEALTHCardinal Health 200, LLCOJF2026-07-06
10198956451179CARDINAL HEALTHCardinal Health 200, LLCOJF2026-06-05
10198956487833CARDINAL HEALTHCardinal Health 200, LLCOJF2026-06-01
10198956488069CARDINAL HEALTHCardinal Health 200, LLCOJF2026-06-01
10193489412796Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489413113Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489413953Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489414783Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489424249Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489427813Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489428483Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489430677Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489431650Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08
10193489432688Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJF2023-06-08