FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956503397
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN4LTPGRF
Catalog number
SEN4LTPGRF
Device description
TYMPANOPLASTY PACK
Published
2026-09-04
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
OGREar, nose, and throat surgical tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGREar, Nose, And Throat Surgical TrayEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956503395PackageGS12In Commercial Distribution
10198956503397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895650339550198956503395
1019895650339710198956503397

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, medicatedA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings, pharmaceuticals, and the necessary materials used to perform an ENT 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
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956463394CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956519534CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956535848CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956540804CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956545540CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956546943CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956547605CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956556270CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956557260CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956560277CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956562394CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956568792CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956569133CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956570320CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956571631CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956573086CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956573093CARDINAL HEALTHCardinal Health 200, LLCOGR2026-09-04
10198956409767CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956502697CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956548336CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956551725CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956557703CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956562134CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956562233CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956563803CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956564565CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-26
10198956463738CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-18
10198956416598CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-17
10198956501799CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-17
10198956547445CARDINAL HEALTHCardinal Health 200, LLCOGR2026-08-17