FDA.reportPublic FDA data

NorthStar

Primary DI
10889981200152
Brand
NorthStar
Company
Seaspine Orthopedics Corporation
Model
PC3-300000
Catalog number
PC3-300000
Device description
Implant Tray Case
Published
2020-06-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OJHOrthopedic tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981200152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998120015210889981200152

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(760)727-8399custsvcspine@seaspine.com

Regulatory Flags#

DUNS number
079840876
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889981442187REEF LRL2-100608RL2-1006082026-06-19
10889981443344REEF LRL3-109002RL3-1090022026-06-19
10889981326234RegattaRP1-200200RP1-2002002025-01-17
10889981326777RegattaRP1-000308RP1-0003082025-01-17
10889981326784RegattaRP1-000310RP1-0003102025-01-17
10889981326791RegattaRP1-000312RP1-0003122025-01-17
10889981326807RegattaRP1-000314RP1-0003142025-01-17
10889981326814RegattaRP1-000316RP1-0003162025-01-17
10889981326821RegattaRP1-000318RP1-0003182025-01-17
10889981326838RegattaRP1-000320RP1-0003202025-01-17
10889981329969RegattaRP3-209300RP3-2093002025-01-17
10889981330002WaveForm LWL4-184015WL4-1840152025-01-17
10889981330026WaveForm LWL4-184515WL4-1845152025-01-17
10889981330040WaveForm LWL4-185015WL4-1850152025-01-17
10889981330064WaveForm LWL4-185515WL4-1855152025-01-17
10889981330088WaveForm LWL4-186015WL4-1860152025-01-17
10889981330101WaveForm LWL4-284015WL4-2840152025-01-17
10889981330125WaveForm LWL4-284515WL4-2845152025-01-17
10889981330149WaveForm LWL4-285015WL4-2850152025-01-17
10889981330163WaveForm LWL4-285515WL4-2855152025-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956538030CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956546424CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956555211CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956561311CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956570177CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956572157CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956572263CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956588912CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956593152CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956594388CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956596894CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956597884CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956598133CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956603943CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956604544CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956605022CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
10198956610712CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-15
B098AMS14856B0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-10-14
10198956537798CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-13
10198956539914CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-13
10198956545182CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-13
10198956549050CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-13
10198956563223CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-13
10198956276437CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956301719CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956333611CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956361041CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956384439CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956388376CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12
10198956519541CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-12