Primary Device ID | 03613720212911 |
NIH Device Record Key | 2f775ed9-e584-43d7-a4ff-1b55b07e011f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PASS LP 2.0 |
Version Model Number | A02336030 |
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 | 03613720212911 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[03613720212911]
Moist Heat or Steam Sterilization
[03613720212911]
Moist Heat or Steam Sterilization
[03613720212911]
Moist Heat or Steam Sterilization
[03613720212911]
Moist Heat or Steam Sterilization
[03613720212911]
Moist Heat or Steam Sterilization
[03613720212911]
Moist Heat or Steam Sterilization
[03613720212911]
Moist Heat or Steam Sterilization
[03613720212911]
Moist Heat or Steam Sterilization
[03613720212911]
Moist Heat or Steam Sterilization
[03613720212911]
Moist Heat or Steam Sterilization
[03613720212911]
Moist Heat or Steam Sterilization
[03613720212911]
Moist Heat or Steam Sterilization
[03613720212911]
Moist Heat or Steam Sterilization
[03613720212911]
Moist Heat or Steam Sterilization
[03613720212911]
Moist Heat or Steam Sterilization
[03613720212911]
Moist Heat or Steam Sterilization
[03613720212911]
Moist Heat or Steam Sterilization
[03613720212911]
Moist Heat or Steam Sterilization
[03613720212911]
Moist Heat or Steam Sterilization
[03613720212911]
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 |