FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439877562
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA11MAENK
Catalog number
SBA11MAENK
Device description
MASTECTOMY PACK
Published
2020-10-02
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
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439877562PackageGS13In Commercial Distribution
10888439877564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843987756250888439877562
1088843987756410888439877564

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. 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
10884521022683Monoject85121851212016-09-24
10884521023437Monoject890689062019-07-19
30884521018444Monoject8990Y8990Y2017-01-06
40884521018298Monoject89671896712016-09-24
40884521018380Monoject8970Y8970Y2017-01-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS17798A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS179150Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190180Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190730Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190920Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS190930Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS194550Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS195260Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-26
B098AMS13932C0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS16019B0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS17843A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS18256A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS187260Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
B098AMS5861D0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-25
10809160527825HalyardAVID MEDICAL, INC.LRO2026-07-24
10809160527788HalyardAVID MEDICAL, INC.LRO2026-07-23
10809160527801HalyardAVID MEDICAL, INC.LRO2026-07-23
10809160527818HalyardAVID MEDICAL, INC.LRO2026-07-23
10809160527726HalyardAVID MEDICAL, INC.LRO2026-07-22
10809160527733HalyardAVID MEDICAL, INC.LRO2026-07-22
10809160527740HalyardAVID MEDICAL, INC.LRO2026-07-22
B098AMS15343A0Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
B098AMS174900Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
B098AMS187270Aligned Medical SolutionsAligned Medical SolutionsLRO2026-07-22
10653160394068CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-07-21
10653160394105MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394150MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394167MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394174MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21
10653160394266MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-07-21