FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956608078
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN11CCCHP
Catalog number
SAN11CCCHP
Device description
CARDIAC CATH PACK
Published
2026-10-29
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
LRPTray, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956608076PackageGS13In Commercial Distribution
10198956608078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895660807650198956608076
1019895660807810198956608078

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
20885380213851CARDINAL HEALTHCH33225CH332252026-11-02
10192253025316Monoject888151123588815112352021-09-17
20884521014999Monoject888151131088815113102016-09-24
20884521014937Monoject888151111088815111102016-09-24
10192253046526Kendall55546BAMD55546BAMD2023-10-09
10192253046786Kendall55588BAMDX55588BAMDX2025-09-09
10885380031687PROTEXIS2D72NT65X2D72NT65X2018-04-13
10192253025309Monoject888151120188815112012021-09-17
10192253069693Curity6309G6309G2026-10-29
10198956253209CARDINAL HEALTHSOTCGUPTRDSOTCGUPTRD2026-10-29
10198956323209CARDINAL HEALTHPGX4LTPREPGX4LTPRE2026-10-29
10198956359888CARDINAL HEALTHSOPOCHAWMCSOPOCHAWMC2026-10-29
10198956381759CARDINAL HEALTH34-6599D34-6599D2026-10-29
10198956423534CARDINAL HEALTHSAN11PD10BSAN11PD10B2026-10-29
10198956428195CARDINAL HEALTHPOV2CHCPUPOV2CHCPU2026-10-29
10198956435292CARDINAL HEALTH03-6720C03-6720C2026-10-29
10198956468184CARDINAL HEALTHSNE7CLMNHMSNE7CLMNHM2026-10-29
10198956485372CARDINAL HEALTHSMA23GLNIGSMA23GLNIG2026-10-29
10198956496101CARDINAL HEALTHSMA4EDCBDCSMA4EDCBDC2026-10-29
10198956503519CARDINAL HEALTHSBA4LGLGRFSBA4LGLGRF2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311264858Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264865Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264872Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264889Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264896Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264902Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264919Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264926Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264933Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264940Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264957Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264964Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264971Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264988Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311264995Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311265015Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311265022Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311265039Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00840311265046Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-11-02
00810017915194ALIF, Disc Prep Bottom LevelELEVATION SPINE, INC.LRP2026-10-30
00642356007298Mastel SurgicalMastel Surgical Inc.LRP2026-10-29
10198956566576CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956589612CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956593879CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956601550CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956609037CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956620421CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956623255CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956623262CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29
10198956623279CARDINAL HEALTHCardinal Health 200, LLCLRP2026-10-29