Sapphire X

GUDID 00840606151344

Sapphire X Fixed Drill Guide 60°

SPINAL ELEMENTS, INC.

Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable Surgical drill guide, reusable
Primary Device ID00840606151344
NIH Device Record Keyab6124c0-3522-401e-8e5c-d47664c1acd5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSapphire X
Version Model Number27022-060
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
GS100840606151344 [Primary]
GS100840606151344 [Primary]
GS100840606151344 [Primary]
GS100840606151344 [Primary]
GS100840606151344 [Primary]
GS100840606151344 [Primary]
GS100840606151344 [Primary]
GS100840606151344 [Primary]
GS100840606151344 [Primary]
GS100840606151344 [Primary]
GS100840606151344 [Primary]
GS100840606151344 [Primary]
GS100840606151344 [Primary]
GS100840606151344 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument
LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840606151344]

Moist Heat or Steam Sterilization


[00840606151344]

Moist Heat or Steam Sterilization


[00840606151344]

Moist Heat or Steam Sterilization


[00840606151344]

Moist Heat or Steam Sterilization


[00840606151344]

Moist Heat or Steam Sterilization


[00840606151344]

Moist Heat or Steam Sterilization


[00840606151344]

Moist Heat or Steam Sterilization


[00840606151344]

Moist Heat or Steam Sterilization


[00840606151344]

Moist Heat or Steam Sterilization


[00840606151344]

Moist Heat or Steam Sterilization


[00840606151344]

Moist Heat or Steam Sterilization


[00840606151344]

Moist Heat or Steam Sterilization


[00840606151344]

Moist Heat or Steam Sterilization


[00840606151344]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-31
Device Publish Date2020-07-23

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

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