FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594501358
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SENDHDOCLI
Catalog number
SENDHDOCLI
Device description
DENTAL OMFS PACK
Published
2022-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OFXGeneral purpose dental tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFXGeneral Purpose Dental TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594501356PackageGS12In Commercial Distribution
10195594501358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559450135650195594501356
1019559450135810195594501358

GMDN Terms#

Term, Definition table
TermDefinition
Dental anaesthesia injection kitA collection of sterile devices designed to inject dental anaesthetics into gingival tissue or the oral mucosa, while preventing or reducing the risk of accidental needle-stick injury, during restorative or surgical dental procedures. It typically includes a syringe, a needle, a needle protection mechanism, and a plunger. This device does not contain the pharmaceuticals which are typically held within a cartridge produced to fit the syringe. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
10198956449596CARDINAL HEALTHCardinal Health 200, LLCOFX2026-07-20
10198956464230CARDINAL HEALTHCardinal Health 200, LLCOFX2026-07-20
10198956453265CARDINAL HEALTHCardinal Health 200, LLCOFX2026-07-06
10198956502895CARDINAL HEALTHCardinal Health 200, LLCOFX2026-06-23
10198956464223CARDINAL HEALTHCardinal Health 200, LLCOFX2026-06-05
08720892104809Crown Cassette 200Rademaker Medical Instruments B.V.OFX2026-06-04
08720892104823Crown Cassette 100Rademaker Medical Instruments B.V.OFX2026-06-04
08720892104847Crown Cassette 300Rademaker Medical Instruments B.V.OFX2026-06-04
08720892104861Crown Cassette 400Rademaker Medical Instruments B.V.OFX2026-06-04
10198956480858CARDINAL HEALTHCardinal Health 200, LLCOFX2026-06-01
10195327485092Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327587352Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327587444Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327593520Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327608170Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327628604Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327654252Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327671099Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327671136Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-07-29
10195327674175Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-04-07
10195327640170Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-03-03
10195327643713Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-03-03
10195327640408Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-02-25
10195327641399Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-02-25
10195327619978Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-02-11
10195327588168Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-01-07
10195327592608Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2024-01-07
10195327582005Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2023-12-31
10195327580599Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2023-12-24
10195327467067Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OFX2023-12-21