RAPHAEL
GUDID 00841732124318
RAPHAEL™ Polyaxial Reduction Screw, LX, 7.5 x L75mm
CTL MEDICAL CORPORATION
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00841732124318 |
| NIH Device Record Key | 440a789c-b5a0-4ef4-866a-f39298449438 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RAPHAEL |
| Version Model Number | 015.4377 |
| 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 | true |
| 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 | 00841732124318 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K132365
FDA Product Code
| KWP | Appliance, Fixation, Spinal Interlaminal |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
[00841732124318]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-15 |
| Device Publish Date | 2023-09-07 |
On-Brand Devices [RAPHAEL]
Trademark Results [RAPHAEL]
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.