FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106626472
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
08-0079A
Catalog number
08-0079A
Device description
LACERATION TRAY
Published
2024-04-26
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
PKAExternal upper esophageal sphincter (UES) compression device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKAExternal Upper Esophageal Sphincter (Ues) Compression DeviceEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106626472PackageGS120In Commercial Distribution
10197106626474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710662647250197106626472
1019710662647410197106626474

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
10197106827376CARDINAL HEALTHCardinal Health 200, LLCPKA2024-12-18
50197106827374CARDINAL HEALTHCardinal Health 200, LLCPKA2024-12-18
10197106743171CARDINAL HEALTHCardinal Health 200, LLCPKA2024-09-26
50197106743179CARDINAL HEALTHCardinal Health 200, LLCPKA2024-09-26
10197106690437CARDINAL HEALTHCardinal Health 200, LLCPKA2024-07-16
50197106690435CARDINAL HEALTHCardinal Health 200, LLCPKA2024-07-16
10197106652015CARDINAL HEALTHCardinal Health 200, LLCPKA2024-06-15
50197106652013CARDINAL HEALTHCardinal Health 200, LLCPKA2024-06-15
10197106655030CARDINAL HEALTHCardinal Health 200, LLCPKA2024-05-16
50197106655038CARDINAL HEALTHCardinal Health 200, LLCPKA2024-05-16
10197106626474CARDINAL HEALTHCardinal Health 200, LLCPKA2024-04-26
10197106524589CARDINAL HEALTHCardinal Health 200, LLCPKA2024-02-29
50197106524587CARDINAL HEALTHCardinal Health 200, LLCPKA2024-02-29
10197106572887CARDINAL HEALTHCardinal Health 200, LLCPKA2024-02-12
50197106572885CARDINAL HEALTHCardinal Health 200, LLCPKA2024-02-12
10197106481875CARDINAL HEALTHCardinal Health 200, LLCPKA2023-12-27
50197106481873CARDINAL HEALTHCardinal Health 200, LLCPKA2023-12-27
10197106293171CARDINAL HEALTHCardinal Health 200, LLCPKA2023-06-23
50197106293179CARDINAL HEALTHCardinal Health 200, LLCPKA2023-06-23
10197106295083CARDINAL HEALTHCardinal Health 200, LLCPKA2023-06-14
50197106295081CARDINAL HEALTHCardinal Health 200, LLCPKA2023-06-14
10197106210567CARDINAL HEALTHCardinal Health 200, LLCPKA2023-05-04
50197106210565CARDINAL HEALTHCardinal Health 200, LLCPKA2023-05-04
10197106191491CARDINAL HEALTHCardinal Health 200, LLCPKA2023-03-29
50197106191499CARDINAL HEALTHCardinal Health 200, LLCPKA2023-03-29