Crystal

GUDID 00840606153300

16MM X 13MM X 11MM 7° TRIAL/RASP 1:1

SPINAL ELEMENTS, INC.

Spinal implant trial

• Primary Device ID: 00840606153300
• NIH Device Record Key: 0683147d-1b5f-49d9-b610-3ce0164ccdab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crystal
• Version Model Number: 20027-711
• Company DUNS: 610712213
• Company Name: SPINAL ELEMENTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840606153300 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument
• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

[00840606153300]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-04
• Device Publish Date: 2019-09-06

On-Brand Devices [Crystal]

• 00840606153331: 14MM X 11MM X 6MM 7° TRIAL/RASP 1:1
• 00840606153324: 14MM X 11MM X 5MM 7° TRIAL/RASP 1:1
• 00840606153317: 16MM X 13MM X 12MM 7° TRIAL/RASP 1:1
• 00840606153300: 16MM X 13MM X 11MM 7° TRIAL/RASP 1:1
• 00840606153294: 16MM X 13MM X 10MM 7° TRIAL/RASP 1:1
• 00840606153287: 16MM X 13MM X 9MM 7° TRIAL/RASP 1:1
• 00840606153270: 16MM X 13MM X 8MM 7° TRIAL/RASP 1:1
• 00840606153263: 16MM X 13MM X 7MM 7° TRIAL/RASP 1:1
• 00840606153256: 16MM X 13MM X 6MM 7° TRIAL/RASP 1:1
• 00840606153249: 16MM X 13MM X 5MM 7° TRIAL/RASP 1:1
• 00840606153522: 14MM X 11MM X 9MM 0° TRIAL/RASP 1:1
• 00840606153515: 14MM X 11MM X 8MM 0° TRIAL/RASP 1:1
• 00840606153508: 14MM X 11MM X 7MM 0° TRIAL/RASP 1:1
• 00840606153492: 14MM X 11MM X 6MM 0° TRIAL/RASP 1:1
• 00840606153485: 14MM X 11MM X 5MM 0° TRIAL/RASP 1:1
• 00840606153478: 16MM X 13MM X 12MM 0° TRIAL/RASP 1:1
• 00840606153461: 16MM X 13MM X 11MM 0° TRIAL/RASP 1:1
• 00840606153454: 16MM X 13MM X 10MM 0° TRIAL/RASP 1:1
• 00840606153447: 16MM X 13MM X 9MM 0° TRIAL/RASP 1:1
• 00840606153430: 16MM X 13MM X 8MM 0° TRIAL/RASP 1:1
• 00840606153423: 16MM X 13MM X 7MM 0° TRIAL/RASP 1:1
• 00840606153416: 16MM X 13MM X 6MM 0° TRIAL/RASP 1:1
• 00840606153409: 16MM X 13MM X 5MM 0° TRIAL/RASP 1:1
• 00840606153393: 14MM X 11MM X 12MM 7° TRIAL/RASP 1:1
• 00840606153386: 14MM X 11MM X 11MM 7° TRIAL/RASP 1:1
• 00840606153379: 14MM X 11MM X 10MM 7° TRIAL/RASP 1:1
• 00840606153362: 14MM X 11MM X 9MM 7° TRIAL/RASP 1:1
• 00840606153355: 14MM X 11MM X 8MM 7° TRIAL/RASP 1:1
• 00840606153348: 14MM X 11MM X 7MM 7° TRIAL/RASP 1:1
• 00840606153676: 14MM X 11MM X 8MM 7° TRIAL/RASP 1:1 NO STOP
• 00840606153669: 14MM X 11MM X 7MM 7° TRIAL/RASP 1:1 NO STOP
• 00840606153652: 14MM X 11MM X 6MM 7° TRIAL/RASP 1:1 NO STOP
• 00840606153645: 14MM X 11MM X 5MM 7° TRIAL/RASP 1:1 NO STOP
• 00840606153638: 16MM X 13MM X 12MM 7° TRIAL/RASP 1:1 NO STOP
• 00840606153621: 16MM X 13MM X 11MM 7° TRIAL/RASP 1:1 NO STOP
• 00840606153614: 16MM X 13MM X 10MM 7° TRIAL/RASP 1:1 NO STOP
• 00840606153607: 16MM X 13MM X 9MM 7° TRIAL/RASP 1:1 NO STOP
• 00840606153591: 16MM X 13MM X 8MM 7° TRIAL/RASP 1:1 NO STOP
• 00840606153584: 16MM X 13MM X 7MM 7° TRIAL/RASP 1:1 NO STOP
• 00840606153577: 16MM X 13MM X 6MM 7° TRIAL/RASP 1:1 NO STOP
• 00840606153560: 16MM X 13MM X 5MM 7° TRIAL/RASP 1:1 NO STOP
• 00840606153553: 14MM X 11MM X 12MM 0° TRIAL/RASP 1:1
• 00840606153546: 14MM X 11MM X 11MM 0° TRIAL/RASP 1:1
• 00840606153539: 14MM X 11MM X 10MM 0° TRIAL/RASP 1:1
• 00840606153935: 14MM X 11MM X 7MM/8MM 0° DUAL TRIAL 1:1
• 00840606153928: 14MM X 11MM X 5MM/6MM 0° DUAL TRIAL 1:1
• 00840606153911: 14MM X 11MM X 11MM/12MM 7° DUAL TRIAL 1:1
• 00840606153904: 14MM X 11MM X 9MM/10MM 7° DUAL TRIAL 1:1
• 00840606153898: 14MM X 11MM X 7MM/8MM 7° DUAL TRIAL 1:1
• 00840606153881: 14MM X 11MM X 5MM/6MM 7° DUAL TRIAL 1:1