Opteryx® CI-040
GUDID M711CI0400
Radel, SST
Innovasis, Inc.
Surgical drill guide, reusable| Primary Device ID | M711CI0400 |
| NIH Device Record Key | b08fadf4-8ee8-4d42-8417-24134064be4e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Opteryx® |
| Version Model Number | CI-040 |
| Catalog Number | CI-040 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M711CI0400 [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 |
[M711CI0400]
Moist Heat or Steam Sterilization
[M711CI0400]
Moist Heat or Steam Sterilization
[M711CI0400]
Moist Heat or Steam Sterilization
[M711CI0400]
Moist Heat or Steam Sterilization
[M711CI0400]
Moist Heat or Steam Sterilization
[M711CI0400]
Moist Heat or Steam Sterilization
[M711CI0400]
Moist Heat or Steam Sterilization
[M711CI0400]
Moist Heat or Steam Sterilization
[M711CI0400]
Moist Heat or Steam Sterilization
[M711CI0400]
Moist Heat or Steam Sterilization
[M711CI0400]
Moist Heat or Steam Sterilization
[M711CI0400]
Moist Heat or Steam Sterilization
[M711CI0400]
Moist Heat or Steam Sterilization
[M711CI0400]
Moist Heat or Steam Sterilization
[M711CI0400]
Moist Heat or Steam Sterilization
[M711CI0400]
Moist Heat or Steam Sterilization
[M711CI0400]
Moist Heat or Steam Sterilization
[M711CI0400]
Moist Heat or Steam Sterilization
[M711CI0400]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-04-06 |
| 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 |
Trademark Results [Opteryx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTERYX 78874706 3350165 Live/Registered |
Innovasis, Inc. 2006-05-02 |
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