FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106244263
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SEN55HPHHA
Catalog number
SEN55HPHHA
Device description
HEAD AND NECK PACK
Published
2023-07-17
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
LRAHearing aid, tactile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRAHearing Aid, TactileUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106244263PackageGS14In Commercial Distribution
10197106244265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710624426350197106244263
1019710624426510197106244265

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956101357CARDINAL HEALTHCardinal Health 200, LLCLRA2025-06-05
10198956102637CARDINAL HEALTHCardinal Health 200, LLCLRA2025-06-05
50198956101355CARDINAL HEALTHCardinal Health 200, LLCLRA2025-06-05
50198956102635CARDINAL HEALTHCardinal Health 200, LLCLRA2025-06-05
10197106833261CARDINAL HEALTHCardinal Health 200, LLCLRA2024-12-10
10197106767566CARDINAL HEALTHCardinal Health 200, LLCLRA2024-10-15
50197106767564CARDINAL HEALTHCardinal Health 200, LLCLRA2024-10-15
10197106754641CARDINAL HEALTHCardinal Health 200, LLCLRA2024-09-27
50197106754649CARDINAL HEALTHCardinal Health 200, LLCLRA2024-09-27
10197106780855CARDINAL HEALTHCardinal Health 200, LLCLRA2024-09-24
50197106780853CARDINAL HEALTHCardinal Health 200, LLCLRA2024-09-24
10197106738931CARDINAL HEALTHCardinal Health 200, LLCLRA2024-08-21
50197106738939CARDINAL HEALTHCardinal Health 200, LLCLRA2024-08-21
10197106660010CARDINAL HEALTHCardinal Health 200, LLCLRA2024-07-05
10197106677438CARDINAL HEALTHCardinal Health 200, LLCLRA2024-07-05
50197106660018CARDINAL HEALTHCardinal Health 200, LLCLRA2024-07-05
50197106677436CARDINAL HEALTHCardinal Health 200, LLCLRA2024-07-05
10197106602065CARDINAL HEALTHCardinal Health 200, LLCLRA2024-04-24
50197106602063CARDINAL HEALTHCardinal Health 200, LLCLRA2024-04-24
10197106604434CARDINAL HEALTHCardinal Health 200, LLCLRA2024-03-20
50197106604432CARDINAL HEALTHCardinal Health 200, LLCLRA2024-03-20
10197106583982CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-15
50197106583980CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-15
10197106569122CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-12
10197106577585CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-12
50197106569120CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-12
50197106577583CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-12
10197106564394CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-02
50197106564392CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-02
10197106513279CARDINAL HEALTHCardinal Health 200, LLCLRA2024-01-23