| Primary Device ID | 00841732116788 |
| NIH Device Record Key | 8ea0e98d-e733-4c9f-8d67-0fec4021754c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RAPHAEL Pedicle Screw System |
| Version Model Number | 115.7034 |
| Company DUNS | 080138504 |
| Company Name | CTL MEDICAL CORPORATION |
| 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 | 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 |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com | |
| Phone | +1(214)545-5820 |
| complaints@ctlmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841732116788 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
[00841732116788]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-18 |