FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50887488951308
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA43DBTS2
Catalog number
SBA43DBTS2
Device description
STRL DR BOYER ACCESSORY PACK
Published
2018-03-26
Public version status
Update
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
OVNSuture kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVNSuture KitGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50887488951308PackageGS14In Commercial Distribution
10887488951300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748895130850887488951308
1088748895130010887488951300

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.

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
10885380213281CARDINAL HEALTHCAH4403CAH44032026-05-27
10192253047486Telfa766776672025-09-08
50885380140233CONVERTORS8337N8337N2018-08-20
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956258662CARDINAL HEALTHCardinal Health 200, LLCOVN2026-04-27
10198956381131CARDINAL HEALTHCardinal Health 200, LLCOVN2026-04-27
10198956299528CARDINAL HEALTHCardinal Health 200, LLCOVN2026-04-09
10198956308206CARDINAL HEALTHCardinal Health 200, LLCOVN2026-04-06
10198956254732CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-03
10198956369351CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-02
10198956410817CARDINAL HEALTHCardinal Health 200, LLCOVN2026-03-02
10198956377479CARDINAL HEALTHCardinal Health 200, LLCOVN2026-02-23
10198956318380CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-30
10198956325135CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-13
10198956252134CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-12
10198956299511CARDINAL HEALTHCardinal Health 200, LLCOVN2026-01-12
10198956201842CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-29
10198956299979CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-29
10198956285712CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-22
10198956249868CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-17
10198956250055CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-17
10198956192966CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-11
10198956199620CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-09
10198956279797CARDINAL HEALTHCardinal Health 200, LLCOVN2025-12-09
10198956241848CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-28
10198956284562CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
10198956284678CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-25
10198956233522CARDINAL HEALTHCardinal Health 200, LLCOVN2025-11-17
10198956219205CARDINAL HEALTHCardinal Health 200, LLCOVN2025-10-20
10198956223288CARDINAL HEALTHCardinal Health 200, LLCOVN2025-10-20
10198956187450CARDINAL HEALTHCardinal Health 200, LLCOVN2025-10-03
10198956185128CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-23
10198956192881CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-22
10198956132313CARDINAL HEALTHCardinal Health 200, LLCOVN2025-09-04