PASS LP 2.0

GUDID 03613720212683

ROD ROTATING WRENCH

MEDICREA INTERNATIONAL

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID03613720212683
NIH Device Record Keybef27cb2-bd53-4a40-9bf1-d92e0962dadf
Commercial Distribution StatusIn Commercial Distribution
Brand NamePASS LP 2.0
Version Model NumberA02320002
Company DUNS383228632
Company NameMEDICREA INTERNATIONAL
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103613720212683 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03613720212683]

Moist Heat or Steam Sterilization


[03613720212683]

Moist Heat or Steam Sterilization


[03613720212683]

Moist Heat or Steam Sterilization


[03613720212683]

Moist Heat or Steam Sterilization


[03613720212683]

Moist Heat or Steam Sterilization


[03613720212683]

Moist Heat or Steam Sterilization


[03613720212683]

Moist Heat or Steam Sterilization


[03613720212683]

Moist Heat or Steam Sterilization


[03613720212683]

Moist Heat or Steam Sterilization


[03613720212683]

Moist Heat or Steam Sterilization


[03613720212683]

Moist Heat or Steam Sterilization


[03613720212683]

Moist Heat or Steam Sterilization


[03613720212683]

Moist Heat or Steam Sterilization


[03613720212683]

Moist Heat or Steam Sterilization


[03613720212683]

Moist Heat or Steam Sterilization


[03613720212683]

Moist Heat or Steam Sterilization


[03613720212683]

Moist Heat or Steam Sterilization


[03613720212683]

Moist Heat or Steam Sterilization


[03613720212683]

Moist Heat or Steam Sterilization


[03613720212683]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-10-14
Device Publish Date2017-02-02

On-Brand Devices [PASS LP 2.0]

03613720212973SACRAL PLATE HOLDER
03613720212966TRANSVERSE PROCESS HOOK INSERTER
03613720212959PEDICLE HOOK INSERTER
03613720212676ROD HOLDER
03613720282921IN-LINE NUTDRIVER
03613720212720FRENCH BENDER
03613720212379PASS LP 2.0 TRAY 6 - HOOKS AND DRC INSTRUMENTS
03613720212331PASS LP 2.0 TRAY 2 - HANDLES, TAPS AND DRIVERS
03613720240105POSITIONING HANDLE
03613720235552Ø 6mm ROD IN-SITU BENDER CORONAL PLANE LEFT
03613720235545Ø 6mm ROD IN-SITU BENDER CORONAL PLANE RIGHT
03613720235538Ø 6mm ROD IN-SITU BENDER SAGITTAL PLANE LEFT
03613720235521Ø 6mm ROD IN-SITU BENDER SAGITTAL PLANE RIGHT
03613720235514Ø 5.5mm ROD IN-SITU BENDER CORONAL PLANE LEFT
03613720235507Ø 5.5mm ROD IN-SITU BENDER CORONAL PLANE RIGHT
03613720235491Ø 5.5mm ROD IN-SITU BENDER SAGITTAL PLANE LEFT
03613720235484Ø 5.5mm ROD IN-SITU BENDER SAGITTAL PLANE RIGHT
03613720235422TAP FOR SCREW Ø 7.5mm
03613720235408TAP FOR SCREW Ø 6.5mm
03613720235385TAP FOR SCREW Ø 5.5mm
03613720235378TAP FOR SCREW Ø 4.5mm
03613720212935TRANSVERSE PROCESS AND LAMINA HOOK STARTER
03613720212928PEDICLE HOOK STARTER
03613720212911COUNTER TORQUE ON ROD
03613720212904COUNTER TORQUE ON SCREW
03613720212898DEROTATION INSTRUMENT
03613720212874NUTDRIVER
03613720212768DOUBLE ACTION DISTRACTOR
03613720212751SINGLE ACTION DISTRACTOR
03613720212744DOUBLE ACTION COMPRESSOR
03613720212737SINGLE ACTION COMPRESSOR
03613720212706ROD GRIPPER
03613720212690ROD PUSHER
03613720212683ROD ROTATING WRENCH
03613720212539PEDICLE PROBE ILIAC STRAIGHT
03613720212522PEDICLE PROBE CURVED
03613720212515PEDICLE PROBE STRAIGHT
03613720212508PEDICLE PROBE HIGH THORACIC
03613720212492PEDICLE PROBE LENKE STYLE
03613720212485SQUARED AWL REAMER
03613720212454SQUARED AWL
03613720212447PEDICLE FEELER STIFF FLEXIBLE
03613720212430PEDICLE FEELER STIFF
03613720212423SHORT SEPARATOR FOR PASS LP 2.0 TRAY
03613720212416LONG SEPARATOR FOR PASS LP 2.0 TRAY
03613720212409BLUE SILICONE MAT FOR PASS LP 2.0 TRAY
03613720212393PASS LP 2.0 LID
03613720212386PASS LP 2.0 TRAY 7 - AUXILIARY TRAY
03613720212362PASS LP 2.0 TRAY 5 - CORONAL / IN-SITU BENDERS AND SACRAL INSTRUMENTS
03613720212355PASS LP 2.0 TRAY 4 - COMPRESSION / DISTRACTION

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