Opteryx® CI-100

GUDID M711CI1000

SST

Innovasis, Inc.

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• Primary Device ID: M711CI1000
• NIH Device Record Key: 8ddca652-56f3-48c0-a93f-653161264232
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opteryx®
• Version Model Number: CI-100
• Catalog Number: CI-100
• Company DUNS: 156567492
• Company Name: Innovasis, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com
• Phone: 801-261-2236
• Email: info@innovasis.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M711CI1000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061147

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

[M711CI1000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-11-03
• Device Publish Date: 2018-01-31

On-Brand Devices [Opteryx®]

• M711CI0600: Radel, SST
• M711CI1100: SST
• M711CI0500: Radel, SST
• M711CI0400: Radel, SST
• M711BCP010: Al, SST, Nylon, Silicone
• M711CI0900: SST
• M711CI1200: Silicone, SST
• M711CI1000: SST