FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594692582
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN48SNST6
Catalog number
SEN48SNST6
Device description
SINUS SURGERY PACK
Published
2022-05-31
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
OAAAid, visual, for nausea

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OAAAid, Visual, For NauseaUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594692580PackageGS14In Commercial Distribution
10195594692582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559469258050195594692580
1019559469258210195594692582

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature040 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
10198956101845CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
10198956102095CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
10198956110205CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
50198956101843CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
50198956102093CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
50198956110203CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-10
10198956101296CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-05
10198956101418CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-05
50198956101294CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-05
50198956101416CARDINAL HEALTHCardinal Health 200, LLCOAA2025-06-05
10197106908792CARDINAL HEALTHCardinal Health 200, LLCOAA2025-01-02
50197106908790CARDINAL HEALTHCardinal Health 200, LLCOAA2025-01-02
10197106824443CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-23
10197106835340CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-23
50197106824441CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-23
50197106835348CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-23
10197106876275CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-20
10197106866498CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-11
50197106866496CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-11
10197106825150CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-06
50197106825158CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-06
10197106852248CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-04
10197106859025CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-04
50197106852246CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-04
50197106859023CARDINAL HEALTHCardinal Health 200, LLCOAA2024-12-04
10197106810248CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-25
50197106810246CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-25
10197106721049CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-15
50197106721047CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-15
10197106796108CARDINAL HEALTHCardinal Health 200, LLCOAA2024-11-13