| Primary Device ID | 03613720212454 |
| NIH Device Record Key | e73f1a8d-ce05-4c3c-b829-22e83395d64d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PASS LP 2.0 |
| Version Model Number | A02310010 |
| Company DUNS | 383228632 |
| Company Name | MEDICREA INTERNATIONAL |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03613720212454 [Primary] |
| HTO | Reamer |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03613720212454]
Moist Heat or Steam Sterilization
[03613720212454]
Moist Heat or Steam Sterilization
[03613720212454]
Moist Heat or Steam Sterilization
[03613720212454]
Moist Heat or Steam Sterilization
[03613720212454]
Moist Heat or Steam Sterilization
[03613720212454]
Moist Heat or Steam Sterilization
[03613720212454]
Moist Heat or Steam Sterilization
[03613720212454]
Moist Heat or Steam Sterilization
[03613720212454]
Moist Heat or Steam Sterilization
[03613720212454]
Moist Heat or Steam Sterilization
[03613720212454]
Moist Heat or Steam Sterilization
[03613720212454]
Moist Heat or Steam Sterilization
[03613720212454]
Moist Heat or Steam Sterilization
[03613720212454]
Moist Heat or Steam Sterilization
[03613720212454]
Moist Heat or Steam Sterilization
[03613720212454]
Moist Heat or Steam Sterilization
[03613720212454]
Moist Heat or Steam Sterilization
[03613720212454]
Moist Heat or Steam Sterilization
[03613720212454]
Moist Heat or Steam Sterilization
[03613720212454]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-10-14 |
| Device Publish Date | 2017-02-02 |
| 03613720212973 | SACRAL PLATE HOLDER |
| 03613720212966 | TRANSVERSE PROCESS HOOK INSERTER |
| 03613720212959 | PEDICLE HOOK INSERTER |
| 03613720212676 | ROD HOLDER |
| 03613720282921 | IN-LINE NUTDRIVER |
| 03613720212720 | FRENCH BENDER |
| 03613720212379 | PASS LP 2.0 TRAY 6 - HOOKS AND DRC INSTRUMENTS |
| 03613720212331 | PASS LP 2.0 TRAY 2 - HANDLES, TAPS AND DRIVERS |
| 03613720240105 | POSITIONING HANDLE |
| 03613720235552 | Ø 6mm ROD IN-SITU BENDER CORONAL PLANE LEFT |
| 03613720235545 | Ø 6mm ROD IN-SITU BENDER CORONAL PLANE RIGHT |
| 03613720235538 | Ø 6mm ROD IN-SITU BENDER SAGITTAL PLANE LEFT |
| 03613720235521 | Ø 6mm ROD IN-SITU BENDER SAGITTAL PLANE RIGHT |
| 03613720235514 | Ø 5.5mm ROD IN-SITU BENDER CORONAL PLANE LEFT |
| 03613720235507 | Ø 5.5mm ROD IN-SITU BENDER CORONAL PLANE RIGHT |
| 03613720235491 | Ø 5.5mm ROD IN-SITU BENDER SAGITTAL PLANE LEFT |
| 03613720235484 | Ø 5.5mm ROD IN-SITU BENDER SAGITTAL PLANE RIGHT |
| 03613720235422 | TAP FOR SCREW Ø 7.5mm |
| 03613720235408 | TAP FOR SCREW Ø 6.5mm |
| 03613720235385 | TAP FOR SCREW Ø 5.5mm |
| 03613720235378 | TAP FOR SCREW Ø 4.5mm |
| 03613720212935 | TRANSVERSE PROCESS AND LAMINA HOOK STARTER |
| 03613720212928 | PEDICLE HOOK STARTER |
| 03613720212911 | COUNTER TORQUE ON ROD |
| 03613720212904 | COUNTER TORQUE ON SCREW |
| 03613720212898 | DEROTATION INSTRUMENT |
| 03613720212874 | NUTDRIVER |
| 03613720212768 | DOUBLE ACTION DISTRACTOR |
| 03613720212751 | SINGLE ACTION DISTRACTOR |
| 03613720212744 | DOUBLE ACTION COMPRESSOR |
| 03613720212737 | SINGLE ACTION COMPRESSOR |
| 03613720212706 | ROD GRIPPER |
| 03613720212690 | ROD PUSHER |
| 03613720212683 | ROD ROTATING WRENCH |
| 03613720212539 | PEDICLE PROBE ILIAC STRAIGHT |
| 03613720212522 | PEDICLE PROBE CURVED |
| 03613720212515 | PEDICLE PROBE STRAIGHT |
| 03613720212508 | PEDICLE PROBE HIGH THORACIC |
| 03613720212492 | PEDICLE PROBE LENKE STYLE |
| 03613720212485 | SQUARED AWL REAMER |
| 03613720212454 | SQUARED AWL |
| 03613720212447 | PEDICLE FEELER STIFF FLEXIBLE |
| 03613720212430 | PEDICLE FEELER STIFF |
| 03613720212423 | SHORT SEPARATOR FOR PASS LP 2.0 TRAY |
| 03613720212416 | LONG SEPARATOR FOR PASS LP 2.0 TRAY |
| 03613720212409 | BLUE SILICONE MAT FOR PASS LP 2.0 TRAY |
| 03613720212393 | PASS LP 2.0 LID |
| 03613720212386 | PASS LP 2.0 TRAY 7 - AUXILIARY TRAY |
| 03613720212362 | PASS LP 2.0 TRAY 5 - CORONAL / IN-SITU BENDERS AND SACRAL INSTRUMENTS |
| 03613720212355 | PASS LP 2.0 TRAY 4 - COMPRESSION / DISTRACTION |