ORBIT

GUDID 00840606166584

ORBIT™ DISCECTOMY INSTRUMENTS TRAY, INSERT

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 Sterilization/disinfection container Sterilization/disinfection container Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable Device sterilization/disinfection container, reusable

• Primary Device ID: 00840606166584
• NIH Device Record Key: d0d4a61b-02db-45df-ad71-6713c41a5db3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORBIT
• Version Model Number: 11501-000-02
• 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	00840606166584 [Primary]

FDA Product Code

• OJH: Orthopedic Tray

Sterilization

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

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

[00840606166584]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-31
• Device Publish Date: 2021-05-21

On-Brand Devices [ORBIT]

• 00840606164344: ORBIT® SHAVER, 11MM
• 00840606164337: ORBIT® SHAVER, 9MM
• 00840606164320: ORBIT® SHAVER, 7MM
• 00840606164313: ORBIT® PIVOT SCRAPER
• 00840606164306: ORBIT® PIVOT RASP
• 00840606164290: ORBIT® PIVOT SCRAPER, SMALL
• 00840606164283: ORBIT® PIVOT SCRAPER, LARGE
• 00840606164900: ORBIT® DISCECTOMY INSTRUMENT SET
• 00840606164894: LUNA XD ACCESSORY INSTRUMENT SET
• 00840606166591: ORBIT™ DISCECTOMY INSTRUMENTS TRAY, LID
• 00840606166584: ORBIT™ DISCECTOMY INSTRUMENTS TRAY, INSERT
• 00840606166577: ORBIT™ DISCECTOMY INSTRUMENTS TRAY, BASE
• 00840606166560: ORBIT™ DISCECTOMY INSTRUMENTS TRAY, ASSEMBLY