FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594040688
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA35BALU2
Catalog number
SBA35BALU2
Device description
BREAST AUGMENTATION PACK
Published
2021-04-23
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
50195594040688PackageGS12In Commercial Distribution
10195594040680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559404068850195594040688
1019559404068010195594040680

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

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
10192253004489SharpSafety85221852212026-09-24
10192253004502Monoject8522Y8522Y2026-09-24
10192253004557Monoject8533Y8533Y2026-09-24
10192253004571Monoject8536SA8536SA2026-09-24
10192253004632SharpSafety8541SA8541SA2026-09-24
10192253005059Monoject89651896512026-09-24
10192253005080Monoject8967Y8967Y2026-09-24
10192253005493Monoject8506Y8506Y2026-09-24
20885380075169CARDINAL HEALTHUSA-N95-SUSA-N95-S2016-08-02
20885380075183CARDINAL HEALTHUSA-N95-RUSA-N95-R2016-08-02
10198956271418CARDINAL HEALTHSMADKCSOGDSMADKCSOGD2026-09-22
10198956273979CARDINAL HEALTHSNE41APFMASNE41APFMA2026-09-22
10198956313897CARDINAL HEALTHSNE69CRWHESNE69CRWHE2026-09-22
10198956320598CARDINAL HEALTH28-1807Z28-1807Z2026-09-22
10198956333758CARDINAL HEALTHSMA73GLKCHSMA73GLKCH2026-09-22
10198956336667CARDINAL HEALTHSBA57PIOHQSBA57PIOHQ2026-09-22
10198956338661CARDINAL HEALTH08-8060I08-8060I2026-09-22
10198956339255CARDINAL HEALTHSAN23CCPRFSAN23CCPRF2026-09-22
10198956346222CARDINAL HEALTHSMAHDRLAGBSMAHDRLAGB2026-09-22
10198956350434CARDINAL HEALTHPE23THMEHPE23THMEH2026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160535523HalyardMEDICAL ACTION INDUSTRIES INC.LRO2026-09-24
10885632538902SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-09-24
10198956273979CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956336667CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956373839CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956388338CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956426283CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956481978CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956495470CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956503700CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956521193CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956530669CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956532052CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956533905CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956547513CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956549555CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956550476CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956554108CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956555877CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956557024CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956557284CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956558427CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956559936CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956561809CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956562059CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956564589CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956565074CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956566163CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956568952CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22
10198956569683CARDINAL HEALTHCardinal Health 200, LLCLRO2026-09-22