FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439653425
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA11CPCHA
Catalog number
SBA11CPCHA
Device description
CLEFT PALATE PACK
Published
2020-01-21
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
50888439653425PackageGS15In Commercial Distribution
10888439653427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843965342550888439653425
1088843965342710888439653427

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.

Sterilization Methods#

Method table
Method

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
10192253072037CARDINAL HEALTHALMASK5ALMASK52026-07-29
10192253072044CARDINAL HEALTHAMMASK4AMMASK42026-07-29
10192253072051CARDINAL HEALTHAXLMASK6AXLMASK62026-07-29
10192253072068CARDINAL HEALTHCHIMASK3CHIMASK32026-07-29
10192253072075CARDINAL HEALTHINFMASK1INFMASK12026-07-29
10192253072082CARDINAL HEALTHNEOMASK0NEOMASK02026-07-29
10192253072105CARDINAL HEALTHTODMASK2TODMASK22026-07-29
10192253025699Dover888876051688887605162023-11-21
10192253025705Dover888876051888887605182023-11-21
10192253025712Dover888876052088887605202023-11-21
10192253025750Dover888876301888887630182023-11-21
10192253025774Dover888876302288887630222023-11-21
10192253026344Dover35603560-2022-04-12
10192253028201Dover62086208-2024-10-14
10192253030365Dover888849206688884920662025-04-07
10192253031836DoverP4P16ULDP4P16ULD-2024-08-22
10192253068573Dover33053305-2026-01-16
10192253068634Dover61556155-2026-01-16
10197106541029CARDINAL HEALTH01A1360C01A1360C2024-03-06
10197106741030CARDINAL HEALTH03-2242D03-2242D2024-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160527948HALYARDAVID MEDICAL, INC.OGR2026-07-28
10197106944028CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956371811CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956395053CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956464636CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956479975CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956483538CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956498754CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956502734CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956509207CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956510852CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956511071CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956516458CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956520691CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956523036CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956530959CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956531086CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956531314CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956531628CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956532274CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956532434CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956533530CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956533837CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956535350CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
10198956536364CARDINAL HEALTHCardinal Health 200, LLCOGR2026-07-27
B098AMS195970Aligned Medical SolutionsAligned Medical SolutionsOGR2026-07-26
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