| Primary Device ID | 00841732108950 |
| NIH Device Record Key | cbdd3c39-b91b-465d-ac43-3fb62f28039c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PICASSO MIS Spinal System |
| Version Model Number | 016.7052 |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841732108950 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841732108950]
Moist Heat or Steam Sterilization
[00841732108950]
Moist Heat or Steam Sterilization
[00841732108950]
Moist Heat or Steam Sterilization
[00841732108950]
Moist Heat or Steam Sterilization
[00841732108950]
Moist Heat or Steam Sterilization
[00841732108950]
Moist Heat or Steam Sterilization
[00841732108950]
Moist Heat or Steam Sterilization
[00841732108950]
Moist Heat or Steam Sterilization
[00841732108950]
Moist Heat or Steam Sterilization
[00841732108950]
Moist Heat or Steam Sterilization
[00841732108950]
Moist Heat or Steam Sterilization
[00841732108950]
Moist Heat or Steam Sterilization
[00841732108950]
Moist Heat or Steam Sterilization
[00841732108950]
Moist Heat or Steam Sterilization
[00841732108950]
Moist Heat or Steam Sterilization
[00841732108950]
Moist Heat or Steam Sterilization
[00841732108950]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-10-05 |
| Device Publish Date | 2016-03-07 |
| 00841732109001 | Cutter, Sleeve, Type 2 |
| 00841732108998 | Anti-Torque Device |
| 00841732108981 | Hex Driver with Torque Limiting T-Handle, 4.5 |
| 00841732108974 | Hex Driver, Shaft, 1/4" Square Male QC, 4.5 |
| 00841732108967 | Hex Driver with Handle, Self-Retention, 4.5 |
| 00841732108950 | Hex Driver with Handle, 3.0 |
| 00841732108943 | Rod Inserter |
| 00841732108936 | Alignment Tool, Percutaneous Screw Head |
| 00841732108929 | Hex Driver, Cannulated, 1/4" Square QC, 4.0 Self-Retention |
| 00841732108912 | Hex Driver, Cannulated, 1/4" Square Male QC, 4.0 |
| 00841732108905 | Tap, Cannulated, 1/4" Square Male QC, 6.5 |
| 00841732108899 | Tap, Cannulated, 1/4" Square Male QC, 5.5 |
| 00841732108882 | Tap, Cannulated, 1/4" Square Male QC, 4.5 |
| 00841732108875 | Drill, Trilobe End, D3.4 (for 4.5/5.0/5.5 Screws) |
| 00841732108868 | Dilator, ID14 x OD17mm |
| 00841732108851 | Dilator, ID10 x OD14mm |
| 00841732108844 | Dilator, ID1.8 x OD10mm |
| 00841732108837 | Percutaneous Straight Rod, D6.0 x L200mm |
| 00841732108820 | Percutaneous Straight Rod, D6.0 x L160mm |
| 00841732108813 | Percutaneous Straight Rod, D6.0 x L150mm |
| 00841732108806 | Percutaneous Straight Rod, D6.0 x L140mm |
| 00841732108790 | Percutaneous Straight Rod, D6.0 x L130mm |
| 00841732108783 | Percutaneous Straight Rod, D6.0 x L120mm |
| 00841732108776 | Percutaneous Straight Rod, D6.0 x L110mm |
| 00841732108769 | Percutaneous Straight Rod, D6.0 x L100mm |
| 00841732108752 | Percutaneous Straight Rod, D6.0 x L90mm |
| 00841732108745 | Percutaneous Straight Rod, D6.0 x L80mm |
| 00841732108738 | Percutaneous Straight Rod, D6.0 x L70mm |
| 00841732108721 | Percutaneous Straight Rod, D6.0 x L65mm |
| 00841732108714 | Percutaneous Straight Rod, D6.0 x L60mm |
| 00841732108707 | Percutaneous Straight Rod, D6.0 x L55mm |
| 00841732108691 | Percutaneous Straight Rod, D6.0 x L50mm |
| 00841732108684 | Percutaneous Straight Rod, D6.0 x L45mm |
| 00841732108677 | Percutaneous Straight Rod, D6.0 x L40mm |
| 00841732108660 | Percutaneous Straight Rod, D6.0 x L35mm |
| 00841732108653 | Percutaneous Curved Rod, D6.0 x L150mm |
| 00841732108646 | Percutaneous Curved Rod, D6.0 x L140mm |
| 00841732108639 | Percutaneous Curved Rod, D6.0 x L130mm |
| 00841732108622 | Percutaneous Curved Rod, D6.0 x L120mm |
| 00841732108615 | Percutaneous Curved Rod, D6.0 x L110mm |
| 00841732108608 | Percutaneous Curved Rod, D6.0 x L100mm |
| 00841732108592 | Percutaneous Curved Rod, D6.0 x L95mm |
| 00841732108585 | Percutaneous Curved Rod, D6.0 x L90mm |
| 00841732108578 | Percutaneous Curved Rod, D6.0 x L85mm |
| 00841732108561 | Percutaneous Curved Rod, D6.0 x L80mm |
| 00841732108554 | Percutaneous Curved Rod, D6.0 x L75mm |
| 00841732108547 | Percutaneous Curved Rod, D6.0 x L70mm |
| 00841732108530 | Percutaneous Curved Rod, D6.0 x L65mm |
| 00841732108523 | Percutaneous Curved Rod, D6.0 x L60mm |
| 00841732108516 | Percutaneous Curved Rod, D6.0 x L55mm |