RAPHAEL
GUDID 00841732121973
CTL MEDICAL CORPORATION
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00841732121973 |
| NIH Device Record Key | 5f1bcbcb-0290-4223-be4f-74e5ee18912d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RAPHAEL |
| Version Model Number | 015.3957 |
| Company DUNS | 080138504 |
| Company Name | CTL MEDICAL CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841732121973 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132365
FDA Product Code
| MNI | Orthosis, spinal pedicle fixation |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
[00841732121973]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-09 |
| Device Publish Date | 2021-07-30 |
On-Brand Devices [RAPHAEL]
Trademark Results [RAPHAEL]
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.