FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956545984
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PNMHPCBHD
Catalog number
PNMHPCBHD
Device description
KIT,PEDIATRIC CRANIOTOMY,HERMA
Published
2026-11-05
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
OJGNeurological tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956545982PackageGS12In Commercial Distribution
10198956545984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895654598250198956545982
1019895654598410198956545984

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
10192253005820Monoject8602U8602U2026-11-05
10192253005837Monoject8605U8605U2026-11-05
10192253005844Monoject8607U8607U2026-11-05
10192253005851Monoject8611U8611U2026-11-05
10192253005868Monoject8612U8612U2026-11-05
10192253043112Argyle888830160688883016062026-08-12
10192253043136Argyle888830161488883016142026-08-12
10192253043143Argyle888830162288883016222026-08-12
10192253043181Argyle888830171388883017132026-08-12
10192253043198Argyle888830172188883017212026-08-12
10198956196308CARDINAL HEALTHPO44KLCSDPO44KLCSD2026-11-05
10198956202214CARDINAL HEALTHSBA11BCNMNSBA11BCNMN2026-11-05
10198956270817CARDINAL HEALTHSOP38THBADSOP38THBAD2026-11-05
10198956341296CARDINAL HEALTHSOPDKATCH7SOPDKATCH72026-11-05
10198956346659CARDINAL HEALTHPNV2LMA01CPNV2LMA01C2026-11-05
10198956347021CARDINAL HEALTHSCV5DOVFANSCV5DOVFAN2026-11-05
10198956377486CARDINAL HEALTHSOP42AAJCGSOP42AAJCG2026-11-05
10198956390423CARDINAL HEALTHSOP34ARBCLSOP34ARBCL2026-11-05
10198956391123CARDINAL HEALTHSBAX3FFOHASBAX3FFOHA2026-11-05
10198956391666CARDINAL HEALTHSEY69BPZEBSEY69BPZEB2026-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956346659CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956500013CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956502352CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956506480CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956513112CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956541443CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956555761CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956558762CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956565685CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956567962CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956568242CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956568563CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956568600CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956582934CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956583788CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956587311CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956588561CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956591387CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956599888CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956604056CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956604094CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956607323CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956607613CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956607699CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956608184CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956608467CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956609501CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956609563CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956609679CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05
10198956609839CARDINAL HEALTHCardinal Health 200, LLCOJG2026-11-05