FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10887488287553
Brand
CARDINAL HEALTH
Company
CARDINAL HEALTH 200, LLC
Model
PGVMALBPRR
Catalog number
PGVMALBPRR
Device description
KIT,ALIF NEURO SPINE, BARNES
Published
2016-03-31
Public version status
Update
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
OJGNeurological tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50887488287551PackageGS11In Commercial Distribution
10887488287553PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748828755150887488287551
1088748828755310887488287553

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular embolization implantation kitA collection of dedicated instruments intended to be used for the implantation of an embolization implant (implant not included). It typically includes devices for arterial access (e.g., needle, introducer, guidewires) and devices to assist introduction and positioning of the implant (e.g., catheter). 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
112164780
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains 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
10809160527610HALYARDAVID MEDICAL, INC.OJG2026-07-21
10198956175303CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956395435CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956398900CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956402706CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956415256CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956483385CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956502574CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956506541CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956508002CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956508040CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956512467CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956512931CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956513198CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956513525CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956514928CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956515550CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956516236CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956525290CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956525436CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956525696CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956527577CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956527775CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956527812CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956527881CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956528024CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956528178CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956528871CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956529120CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20
10198956530515CARDINAL HEALTHCardinal Health 200, LLCOJG2026-07-20