FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106093085
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
ANE735863A
Catalog number
ANE735863A
Device description
KIT, ANESTHESIA
Published
2023-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRPTRAY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106093083PackageGS110In Commercial Distribution
10197106093085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710609308350197106093083
1019710609308510197106093085

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
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
00198506093746ELMED INCORPORATEDELMED INCORPORATEDLRP2026-07-22
00642356005645SteriBestMastel Surgical Inc.LRP2026-07-22
00840311264032Cortera Spinal Fixation SystemXtant Medical Holdings, Inc.LRP2026-07-20
10198956493353CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956501836CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956514683CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956516762CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956518896CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956519589CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956528093CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956529182CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956532502CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956532779CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956532786CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956533516CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956533752CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956535091CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-20
10198956493612CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
10198956501973CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
10198956526181CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
10198956530935CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
10198956531925CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-16
03661219527046DELACROIX-CHEVALIERLANDANGERLRP2026-07-12
10198956392977CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956449992CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956482401CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956499195CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956505513CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956507180CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09
10198956518438CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-09