Sapphire X

GUDID 00840606161527

SAPPHIRE X IMPLANT & INSTRUMENT TRAY, LID

SPINAL ELEMENTS, INC.

Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container
Primary Device ID00840606161527
NIH Device Record Key20ccfabf-70e2-4a64-8888-958abb26c1d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSapphire X
Version Model Number27000-000-08
Company DUNS610712213
Company NameSPINAL ELEMENTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840606161527 [Primary]
GS100840606161527 [Primary]
GS100840606161527 [Primary]
GS100840606161527 [Primary]
GS100840606161527 [Primary]
GS100840606161527 [Primary]
GS100840606161527 [Primary]
GS100840606161527 [Primary]
GS100840606161527 [Primary]
GS100840606161527 [Primary]
GS100840606161527 [Primary]
GS100840606161527 [Primary]
GS100840606161527 [Primary]
GS100840606161527 [Primary]

FDA Product Code

OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray
OJHOrthopedic Tray

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840606161527]

Moist Heat or Steam Sterilization


[00840606161527]

Moist Heat or Steam Sterilization


[00840606161527]

Moist Heat or Steam Sterilization


[00840606161527]

Moist Heat or Steam Sterilization


[00840606161527]

Moist Heat or Steam Sterilization


[00840606161527]

Moist Heat or Steam Sterilization


[00840606161527]

Moist Heat or Steam Sterilization


[00840606161527]

Moist Heat or Steam Sterilization


[00840606161527]

Moist Heat or Steam Sterilization


[00840606161527]

Moist Heat or Steam Sterilization


[00840606161527]

Moist Heat or Steam Sterilization


[00840606161527]

Moist Heat or Steam Sterilization


[00840606161527]

Moist Heat or Steam Sterilization


[00840606161527]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-14
Device Publish Date2020-09-04

On-Brand Devices [Sapphire X]

00840606160438SAPPHIRE X, AWL-DRILL SLEEVE CAP
00840606160421SAPPHIRE X, AWL-DRILL SLEEVE
00840606160414SAPPHRIE X, 10MM AWL
00840606160407SAPPHIRE X, AWL-DRILL, TRIPLE FLUTE Ø2.0 X 18MM
00840606160391SAPPHIRE X, AWL-DRILL, TRIPLE FLUTE Ø2.0 X 16MM
00840606160384SAPPHIRE X, AWL-DRILL, TRIPLE FLUTE Ø2.0 X 14MM
00840606160377SAPPHIRE X, AWL-DRILL, TRIPLE FLUTE Ø2.0 X 12MM
00840606160360SAPPHIRE X, AWL-DRILL, DOUBLE FLUTE Ø2.0 X 10MM
00840606160353SAPPHIRE X, AWL-DRILL, DOUBLE FLUTE Ø2.0 X 18MM
00840606160346SAPPHIRE X, AWL-DRILL, DOUBLE FLUTE Ø2.0 X 16MM
00840606160339SAPPHIRE X, AWL-DRILL, DOUBLE FLUTE Ø2.0 X 14MM
00840606160322SAPPHIRE X, AWL-DRILL, DOUBLE FLUTE Ø2.0 X 12MM
00840606160315SAPPHIRE X, AWL-DRILL, DOUBLE FLUTE Ø2.0 X 10MM
00840606151344Sapphire X Fixed Drill Guide 60°
00840606151337Sapphire X Fixed Drill Guide 45°
00840606151320Sapphire X Fixed Drill Guide 30°
00840606151313Sapphire X Fixed Drill Guide 15°
008406061607731-Level Sapphire X Cervical Plate, 20mm
008406061599821-Level Sapphire X Cervical Plate, 18mm
008406061599751-Level Sapphire X Cervical Plate, 16mm
008406061599681-Level Sapphire X Cervical Plate, 14mm
008406061599511-Level Sapphire X Cervical Plate, 13mm
008406061599441-Level Sapphire X Cervical Plate, 12mm
008406061599371-Level Sapphire X Cervical Plate, 11mm
008406061599201-Level Sapphire X Cervical Plate, 10mm
008406061599131-Level Sapphire X Cervical Plate, 9mm
008406061599061-Level Sapphire X Cervical Plate, 8mm
00840606161695SAPPHIRE X FIXED ANGLE SCREW, CADDY, LID
00840606161688SAPPHIRE X FIXED ANGLE SCREW, CADDY, BASE
00840606161671SAPPHIRE X FIXED ANGLE SCREW, CADDY ASSEMBLY
00840606161664SAPPHIRE X 1-LEVEL PLATE, CADDY, LID
00840606161657SAPPHIRE X 1-LEVEL PLATE, CADDY, BASE
00840606161640SAPPHIRE X 1-LEVEL PLATE, CADDY ASSEMBLY
00840606161633SAPPHIRE X VARIABLE ANGLE SCREW, CADDY, LID
00840606161626SAPPHIRE X VARIABLE ANGLE SCREW, CADDY, BASE
00840606161619SAPPHIRE X VARIABLE ANGLE SCREW, CADDY ASSEMBLY
0084060616160216MM X 13MM 7° TI-BOND INTERBODY CAGE, CADDY, LID
0084060616159616MM X 13MM 7° TI-BOND INTERBODY CAGE, CADDY, BASE
0084060616158916MM X 13MM 7° TI-BOND INTERBODY CAGE, CADDY ASSEMBLY
0084060616157214MM X 11MM 7° TI-BOND INTERBODY CAGE, CADDY, LID
0084060616156514MM X 11MM 7° TI-BOND INTERBODY CAGE, CADDY, BASE
0084060616155814MM X 11MM 7° TI-BOND INTERBODY CAGE, CADDY ASSEMBLY
00840606161541SAPPHIRE X IMPLANT & INSTRUMENT TRAY, CADDY INSERT
00840606161534SAPPHIRE X IMPLANT & INSTRUMENT TRAY, INSTRUMENT INSERT
00840606161527SAPPHIRE X IMPLANT & INSTRUMENT TRAY, LID
00840606161510SAPPHIRE X IMPLANT & INSTRUMENT TRAY, BASE
00840606161503SAPPHIRE X IMPLANT & INSTRUMENT TRAY, ASSEMBLY

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