Nautilus Spinal System 2014-0017

GUDID 00190837055523

Gear Shift

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837055523
NIH Device Record Keya3f2072f-8f03-483b-8283-a6e25b593999
Commercial Distribution StatusIn Commercial Distribution
Brand NameNautilus Spinal System
Version Model Number2014-0017
Catalog Number2014-0017
Company DUNS183641617
Company NameLife Spine, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS100190837055523 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837055523]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-15
Device Publish Date2019-11-07

On-Brand Devices [Nautilus Spinal System]

00190837021771485-35-52
00190837021764485-30-52
00190837021757475-55-52
00190837021740465-60-52
00190837021733465-55-52
00190837021726455-55-52
00190837021719445-50-42
00190837021702445-45-42
00190837021696445-40-42
00190837021689445-35-42
00190837021672445-30-42
00190837007706445-40-52
00190837007690445-35-52
00190837007683445-30-52
00190837007676475-50-52
00190837007669475-45-52
00190837007652475-40-52
00190837007645475-35-52
00190837007638475-30-52
00190837007621465-50-52
00190837007614465-45-52
00190837007607465-40-52
00190837007591465-35-52
00190837007584465-30-52
00190837007577455-50-52
00190837007560455-45-52
00190837007553455-40-52
00190837007546455-35-52
00190837007539455-30-52
001908370075221385-50-52
001908370075151385-45-52
001908370075081385-40-52
001908370074921385-35-52
001908370074851385-30-52
001908370074781375-50-52
001908370074611375-45-52
001908370074541375-40-52
001908370074471375-35-52
001908370074301375-30-52
001908370074231365-50-52
001908370074161365-45-52
001908370074091365-40-52
001908370073931365-35-52
001908370073861365-30-52
001908370073791355-50-52
001908370073621355-45-52
001908370073551355-40-52
001908370073481355-35-52
001908370073311355-30-52
00190837007324785-55-5
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