FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956569584
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34A2053H
Catalog number
34A2053H
Device description
HORNER PROCEDURE TRAY
Published
2026-09-29
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
OFQAnesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFQAnesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956569582PackageGS120In Commercial Distribution
10198956569584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895656958250198956569582
1019895656958410198956569584

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

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
10198956428201CARDINAL HEALTH26-2755C26-2755C2026-10-01
10198956512474CARDINAL HEALTH28A5420I28A5420I2026-10-01
10198956524316CARDINAL HEALTH34A5387R34A5387R2026-10-01
10198956537385CARDINAL HEALTH28-6325B28-6325B2026-10-01
10198956563087CARDINAL HEALTH34-2454E34-2454E2026-10-01
10198956587298CARDINAL HEALTH40-6487C40-6487C2026-10-01
10885380214714Curity8441368441362026-09-30
10885380214738Curity8441568441562026-09-30
10885380214707Curity8441268441262026-09-28
10885380214721Curity8441468441462026-09-28
10885380214745Curity8441668441662026-09-28
10885380214752Curity8441768441762026-09-28
10885380214769Curity8442168442162026-09-28
10885380214776Curity8442268442262026-09-28
10885380214783Curity8442368442362026-09-28
10885380214790Curity8442468442462026-09-28
10885380214806Curity8442568442562026-09-28
20192253017561Medi-Trace Cadence22660P22660P2024-02-28
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
50885380050365CARDINAL HEALTHCA901CHCA901CH2021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956524316CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-10-01
10198956593268CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-30
10198956471672CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-29
10198956559547CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-29
10198956540408CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-25
10198956569508CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-25
10198956580343CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-25
10198956581470CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-25
10198956569324CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-21
10198956572560CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-21
10198956573444CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-21
10198956577091CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-21
10198956465510CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956535558CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956538344CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956538818CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956554610CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956564138CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956549616CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-26
10198956547360CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-18
10198956551442CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-18
10198956394773CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-17
10198956533066CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-17
10198956461734CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956511798CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956524651CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956530706CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956531024CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956531031CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956435728CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-20