FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106827376
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
05-5400A
Catalog number
05-5400A
Device description
ER LACERATION TRAY
Published
2024-12-18
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
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
50197106827374PackageGS120In Commercial Distribution
10197106827376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710682737450197106827374
1019710682737610197106827376

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.

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
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00866736000307Reflux BandThe Reflux CompanyPKA2026-10-08
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
50197106626472CARDINAL 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