PGI

GUDID 00887517061249

PGI Lamina Spreader, TLIF

Nuvasive, Inc.

External spinal fixation system
Primary Device ID00887517061249
NIH Device Record Key29d89d58-34dc-494b-a4b3-ac130003004d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePGI
Version Model Number1010244
Company DUNS053950783
Company NameNuvasive, Inc.
Device Count1
DM Exemptfalse
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

Customer Support Contacts

Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com
Phone+1(858)909-1800
EmailRA_UDI@nuvasive.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100887517061249 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00887517061249]

Moist Heat or Steam Sterilization

[00887517061249]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-25
Device Publish Date2018-09-24

On-Brand Devices [PGI]

00887517521248Posterior Gen Ins Microscope Set
00887517521200Posterior General Ins Set
00887517502926PGI Distractor, Open Counter Torque
00887517422309PGI Disc Cutter, 8mm Micro
00887517419989PGI Rongeur, Pituitary Up Biting
00887517419972PGI Rongeur, Pituitary Straight
00887517419958PGI Rasp, Angled
00887517419941PGI Rasp, Straight
00887517419934PGI Curette, Up Angled
00887517419927PGI Curette, Down Angled
00887517419910PGI Curette, Right Angled
00887517419903PGI Curette, Left Angled
00887517419590PGI Curette, Straight
00887517419071PGI Disc Cutter, 12mm
00887517419064PGI Disc Cutter, 10mm
00887517419057PGI Disc Cutter, 8mm
00887517269591PGI Penfield Dissector, 7mm
00887517269584PGI Penfield Dissector, 4mm
00887517238467PGI T-Handle, Slapping
00887517061249PGI Lamina Spreader, TLIF
00887517060334PGI Dissector, 7mm TLIF
00887517060327PGI Dissector, 4mm TLIF
00887517058072PGI Chisel, 7mm Angled
00887517058065PGI Chisel, 12mm Straight
00887517058058PGI Chisel, 7mm Straight
00887517938183PGI II Paddle Shaver, 9mm
00887517938176PGI II Paddle Shaver, 8mm
00887517938169PGI II Paddle Shaver, 7mm
00887517938152PGI II Paddle Shaver, 6mm
00887517054029PGI Decorticator, 8mm PLIF
00887517054012PGI Decorticator, 14mm PLIF
00887517054005PGI Decorticator, 12mm PLIF
00887517053695PGI Decorticator, 10mm PLIF
00887517943101PGI II Curette, Bayonetted Rt Sharp Lg
00887517943095PGI II Curette, Bayonetted Rt Sharp Sm
00887517943088PGI II Curette, Bayonetted Left Sharp Lg
00887517943071PGI II Curette, Bayonetted Left Sharp Sm
00887517943064PGI II Curette, Bayonetted Down Sharp Lg
00887517943057PGI II Curette, Bayonetted Down Sharp Sm
00887517943040PGI II Curette, Bayonetted Up Sharp Lg
00887517943033PGI II Curette, Bayonetted Up Sharp Sm
00887517943026PGI II Curette, Bayonetted Str Sharp Lg
00887517943019PGI II Curette, Bayonetted Str Sharp Sm
00887517938954PGI II Curette, Large Bayoneted Right
00887517938947PGI II Curette, Small Bayoneted Right
00887517938930PGI II Curette, Large Bayoneted Left
00887517938923PGI II Curette, Small Bayoneted Left
00887517938916PGI II Curette, Large Bayoneted Down
00887517938909PGI II Curette, Small Bayoneted Down
00887517938893PGI II Curette, Large Bayoneted Up
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