| Primary Device ID | 03613720294504 |
| NIH Device Record Key | b3165c5c-c739-4391-8c3e-2df5b950cfd6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PASS LP SPINAL SYSTEM |
| Version Model Number | B02218580 |
| Company DUNS | 383228632 |
| Company Name | MEDICREA INTERNATIONAL |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03613720294504 [Primary] |
| NKB | Thoracolumbosacral pedicle screw system |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
[03613720294504]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-01 |
| Device Publish Date | 2024-07-24 |
| 03613720295532 | CONNECTOR B06020860 SHRT STD FOR 6MM ROD |
| 03613720295525 | CONNECTOR B06020455 SHORT INITIAL 5.5MM |
| 03613720295518 | SCREW B02518560 DUAL LEAD 8.5X60MM |
| 03613720295501 | SCREW B02518555 DUAL LEAD 8.5X55MM |
| 03613720295495 | SCREW B02518550 DUAL LEAD 8.5X50MM |
| 03613720295488 | SCREW B02518545 DUAL LEAD 8.5X45MM |
| 03613720295471 | SCREW B02518540 DUAL LEAD 8.5X40MM |
| 03613720295464 | SCREW B02518535 DUAL LEAD 8.5X35MM |
| 03613720295457 | SCREW B02518530 DUAL LEAD 8.5X30MM |
| 03613720295440 | SCREW B02517560 DUAL LEAD 7.5X60MM |
| 03613720295433 | SCREW B02517555 DUAL LEAD 7.5X55MM |
| 03613720295426 | SCREW B02517550 DUAL LEAD 7.5X50MM |
| 03613720295419 | SCREW B02517545 DUAL LEAD 7.5X45MM |
| 03613720295402 | SCREW B02517540 DUAL LEAD 7.5X40MM |
| 03613720295396 | SCREW B02517535 DUAL LEAD 7.5X35MM |
| 03613720295389 | SCREW B02517530 DUAL LEAD 7.5X30MM |
| 03613720295372 | SCREW B02516560 DUAL LEAD 6.5X60MM |
| 03613720295365 | SCREW B02516555 DUAL LEAD 6.5X55MM |
| 03613720295358 | SCREW B02516550 DUAL LEAD 6.5X50MM |
| 03613720295341 | SCREW B02516545 DUAL LEAD 6.5X45MM |
| 03613720295334 | SCREW B02516540 DUAL LEAD 6.5X40MM |
| 03613720295327 | SCREW B02516535 DUAL LEAD 6.5X35MM |
| 03613720295310 | SCREW B02516530 DUAL LEAD 6.5X30MM |
| 03613720295303 | SCREW B02515555 DUAL LEAD 5.5X55MM |
| 03613720295297 | SCREW B02515550 DUAL LEAD 5.5X50MM |
| 03613720295280 | SCREW B02515545 DUAL LEAD 5.5X45MM |
| 03613720295273 | SCREW B02515540 DUAL LEAD 5.5X40MM |
| 03613720295266 | SCREW B02515535 DUAL LEAD 5.5X35MM |
| 03613720295259 | SCREW B02515530 DUAL LEAD 5.5X30MM |
| 03613720295242 | SCREW B02515525 DUAL LEAD 5.5X25MM |
| 03613720295235 | SCREW B02515055 PEDICLE 5.0X55MM |
| 03613720295228 | SCREW B02515045 PEDICLE 5.0X45MM |
| 03613720295211 | SCREW B02515040 PEDICLE 5.0X40MM |
| 03613720295204 | SCREW B02515035 PEDICLE 5.0X35MM |
| 03613720295198 | SCREW B02515030 PEDICLE 5.0X30MM |
| 03613720295181 | SCREW B02515025 PEDICLE 5.0X25MM |
| 03613720295174 | SCREW B02514545 DUAL LEAD 4.5X45MM |
| 03613720295167 | SCREW B02514540 DUAL LEAD 4.5X40MM |
| 03613720295150 | SCREW B02514535 DUAL LEAD 4.5X35MM |
| 03613720295143 | SCREW B02514530 DUAL LEAD 4.5X30MM |
| 03613720295136 | SCREW B02514525 DUAL LEAD 4.5X25MM |
| 03613720295129 | SCREW B02416545 CANNULA DUAL 6.5X45MM |
| 03613720295112 | SCREW B02416535 CANNULA DUAL 6.5X35MM |
| 03613720295105 | CROSSLINK B02366010 UPSIDE DOWN 6MM S |
| 03613720295099 | CONNECTOR B02336087 LEFT AXIAL SHORT |
| 03613720295082 | CONNECTOR B02336086 RIGHT AXIAL SHORT |
| 03613720295075 | CONNECTOR B02336080 AXIAL SHORT |
| 03613720295068 | CONNECTOR B02286010 ILIAC LINK 6MM ROD |
| 03613720295051 | CROSSLINK B02266020 6.0MM ROD MEDIUM |
| 03613720295044 | CROSSLINK B02266010 6.0MM ROD SMALL |