FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956505421
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA11OMUHC
Catalog number
SBA11OMUHC
Device description
OMFS PACK
Published
2026-07-20
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
50198956505429PackageGS12In Commercial Distribution
10198956505421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895650542950198956505429
1019895650542110198956505421

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, single-useA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a single-use device.

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
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
10198956218536CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956364523CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956367326CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956396180CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956435858CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956443761CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956443815CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956443839CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956503243CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956503403CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956505698CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956506671CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956508200CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956513440CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956514034CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956514072CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956514584CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956516557CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956520189CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956523012CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956525689CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956526426CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956528031CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956528703CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956529267CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956530454CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956530539CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956530553CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956531352CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20
10198956532700CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-20