Interspinous Plate System 29-0007

GUDID 00815362022191

Tissue Awl

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00815362022191
NIH Device Record Key7e4e7921-0524-451f-8f76-8450414f3027
Commercial Distribution StatusIn Commercial Distribution
Brand NameInterspinous Plate System
Version Model Number29-0007
Catalog Number29-0007
Company DUNS079398589
Company NamePRECISION SPINE, INC.
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 Batchfalse
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
GS100815362022191 [Primary]

FDA Product Code

HWJAwl

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815362022191]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-11
Device Publish Date2019-04-03

On-Brand Devices [Interspinous Plate System]

0081536202211555mm Interspinous Female Plate
0081536202210850mm Interspinous Female Plate
0081536202209245mm Interspinous Female Plate
0081536202208540mm Interspinous Female Plate
0081536202207835mm Interspinous Female Plate
0081536202206155mm Interspinous Male Plate
0081536202205450mm Interspinous Male Plate
0081536202204745mm Interspinous Male Plate
0081536202203040mm Interspinous Male Plate
0081536202202335mm Interspinous Male Plate
00815362022603Self Drilling Ø4.0mm Fixed Screw 12mm
00815362022597Self Drilling Ø4.0mm Fixed Screw 10mm
00815362022580Self Drilling Ø4.5mm Variable Screw 20mm
00815362022573Self Drilling Ø4.5mm Variable Screw 18mm
00815362022566Self Drilling Ø4.5mm Variable Screw 16mm
00815362022559Self Drilling Ø4.5mm Variable Screw 14mm
00815362022542Self Drilling Ø4.5mm Variable Screw 12mm
00815362022535Self Drilling Ø4.5mm Variable Screw 10mm
00815362022528Self Drilling Ø4.0mm Variable Screw 20mm
00815362022511Self Drilling Ø4.0mm Variable Screw 18mm
00815362022504Self Drilling Ø4.0mm Variable Screw 16mm
00815362022498Self Drilling Ø4.0mm Variable Screw 14mm
00815362022481Self Drilling Ø4.0mm Variable Screw 12mm
00815362022474Self Drilling Ø4.0mm Variable Screw 10mm
00815362022450AIO Final Tightener
00815362022443AIO Cap Screw Inserter
00815362022436All In One Inserter
0081536202242930mm Trial
0081536202241228mm Trial
0081536202240530mm Interspinous Female Plate
00815362022399Reli™ SP 30mm Interspinous Male Plate
00815362022382Reli™ SP 28mm Interspinous Female Plate
00815362022375Reli™ SP 28mm Interspinous Male Plate
00815362022351ISP Retractor Sterilization Case
00815362022337ISP Sterilization Case
00815362022320Straight Plate Holder
00815362022313Plate Holder
0081536202230690mm Caspar Sleeve
0081536202229075mm Caspar Sleeve
00815362022283Caspar Pin Driver
00815362022276Caspar Retractor
0081536202226910mm Drill
00815362022252Parallel Compressor
0081536202224555mm Trial
0081536202223850mm Trial
0081536202222145mm Trial
0081536202221440mm Trial
0081536202220735mm Trial
00815362022191Tissue Awl
00815362022184Counter Torque

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