| Primary Device ID | 00841732109483 |
| NIH Device Record Key | 2e58567e-b6fb-4fdd-b88c-2abb86593cd9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PICASSO II MIS Spinal System |
| Version Model Number | 019.7091 |
| 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 | 00841732109483 [Primary] |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841732109483]
Moist Heat or Steam Sterilization
[00841732109483]
Moist Heat or Steam Sterilization
[00841732109483]
Moist Heat or Steam Sterilization
[00841732109483]
Moist Heat or Steam Sterilization
[00841732109483]
Moist Heat or Steam Sterilization
[00841732109483]
Moist Heat or Steam Sterilization
[00841732109483]
Moist Heat or Steam Sterilization
[00841732109483]
Moist Heat or Steam Sterilization
[00841732109483]
Moist Heat or Steam Sterilization
[00841732109483]
Moist Heat or Steam Sterilization
[00841732109483]
Moist Heat or Steam Sterilization
[00841732109483]
Moist Heat or Steam Sterilization
[00841732109483]
Moist Heat or Steam Sterilization
[00841732109483]
Moist Heat or Steam Sterilization
[00841732109483]
Moist Heat or Steam Sterilization
[00841732109483]
Moist Heat or Steam Sterilization
[00841732109483]
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 | 2016-03-07 |
| 00841732109490 | Distractor |
| 00841732109483 | Compressor |
| 00841732109476 | Hex Driver with Torque Limiting T-Handle, 5.0 (12 N-m) |
| 00841732109469 | Hex Driver, 1/4" Square QC, 5.0 with Shoulder |
| 00841732109452 | Hex Driver with Handle, 5.0 with Shoulder |
| 00841732109445 | Hex Driver, 1/4" Square QC, 4.0, Cannulated |
| 00841732109438 | Tap, Cannulated, 1/4" Square QC, 7.5 |
| 00841732109421 | Tap, Cannulated, 1/4" Square QC, 6.5 |
| 00841732109414 | Tap, Cannulated, 1/4" Square QC, 5.5 |
| 00841732109407 | Tap, Cannulated, 1/4" Square QC, 4.5 |
| 00841732109391 | Tap, 1/4" Square QC, 7.5 |
| 00841732109384 | Tap, 1/4" Square QC, 6.5 |
| 00841732109377 | Tap, 1/4" Square QC, 5.5 |
| 00841732109360 | Tap, 1/4" Square QC, 4.5 |
| 00841732109353 | Drill, Cannulated, 1/4" Square QC, D5.0mm |
| 00841732109346 | Drill, Cannulated, 1/4" Square QC, D4.2mm |
| 00841732109339 | Drill, Cannulated, 1/4" Square QC, D3.4mm |
| 00841732109322 | Drill, 1/4" Square QC, D5.0mm |
| 00841732109315 | Drill, 1/4" Square QC, D4.2mm |
| 00841732109308 | Drill, 1/4" Square QC, D3.4mm |
| 00841732109292 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D7.5 x L60mm |
| 00841732109285 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D7.5 x L55mm |
| 00841732109278 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D7.5 x L50mm |
| 00841732109261 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D7.5 x L45mm |
| 00841732109254 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D7.5 x L40mm |
| 00841732109247 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D7.5 x L35mm |
| 00841732109230 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D7.5 x L30mm |
| 00841732109223 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D6.5 x L60mm |
| 00841732109216 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D6.5 x L55mm |
| 00841732109209 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D6.5 x L50mm |
| 00841732109193 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D6.5 x L45mm |
| 00841732109186 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D6.5 x L40mm |
| 00841732109179 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D6.5 x L35mm |
| 00841732109162 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D6.5 x L30mm |
| 00841732109155 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D5.5 x L60mm |
| 00841732109148 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D5.5 x L55mm |
| 00841732109131 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D5.5 x L50mm |
| 00841732109124 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D5.5 x L45mm |
| 00841732109117 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D5.5 x L40mm |
| 00841732109100 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D5.5 x L35mm |
| 00841732109094 | PICASSO™ II Percutaneous Polyaxial Screw - Closed Type 127mm, D5.5 x L30mm |
| 00841732109087 | Set Screw, Polyaxial Screwhead |