FDA.reportPublic FDA data

SAPPHIRE X

Primary DI
00840606161534
Brand
SAPPHIRE X
Company
SPINAL ELEMENTS, INC.
Model
27000-000-09
Device description
SAPPHIRE X® IMPLANT & INSTRUMENT TRAY, INSTRUMENT INSERT
Published
2020-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00840606161534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606161534008406061615348406061615340840606161534

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection containerA receptacle designed to hold wrapped and/or unwrapped medical devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots for microsurgical instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
610712213
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840606104074Hero01001-0012015-07-08
00840606104081Hero01001-0022015-07-08
00840606104098Hero01001-0052015-07-08
00840606104104Hero01001-0102015-07-08
00840606104111Hero01002-0012015-07-08
00840606104128Hero01002-0032015-07-08
00840606104135Hero01002-0082015-07-08
00840606104142Hero01003-0012015-07-08
00840606104159Hero01003-0052015-07-08
00840606104166Hero01003-0102015-07-08
00840606104173Hero01004-0052015-07-08
00840606104180Hero01004-0102015-07-08
00840606191425Primus66580-0012026-09-30
00840606191432Primus66580-0022026-09-30
00840606191449Primus66581-0102026-09-30
00840606191456Primus66581-0122026-09-30
00840606191500Primus66623-0002026-09-30
00840606105927LOTUS32535-0102019-02-01
00840606105934LOTUS32535-0122019-02-01
00840606105941LOTUS32535-0142019-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956286672CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956301511CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956306059CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956354494CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956379824CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956402416CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956439702CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956470163CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956512146CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956514522CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956519985CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956523555CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956532083CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956543089CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956543942CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956545359CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956548855CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956548916CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956548961CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956552012CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956552098CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956554696CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956556102CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956556690CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956560796CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956562721CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956567399CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956567696CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956568129CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06
10198956568747CARDINAL HEALTHCardinal Health 200, LLCOJH2026-10-06