Nautilus Spinal System 2016-0148

GUDID 00190837056032

Nautilus Ancillary Driver, T20 Non-cannulated, T-Handle

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837056032
NIH Device Record Keyab9b4971-b42f-4144-b078-38cfd0824617
Commercial Distribution StatusIn Commercial Distribution
Brand NameNautilus Spinal System
Version Model Number2016-0148
Catalog Number2016-0148
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
GS100190837056032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837056032]

Moist Heat or Steam Sterilization

[00190837056032]

Moist Heat or Steam Sterilization

[00190837056032]

Moist Heat or Steam Sterilization

[00190837056032]

Moist Heat or Steam Sterilization

[00190837056032]

Moist Heat or Steam Sterilization

[00190837056032]

Moist Heat or Steam Sterilization

[00190837056032]

Moist Heat or Steam Sterilization

[00190837056032]

Moist Heat or Steam Sterilization

[00190837056032]

Moist Heat or Steam Sterilization

[00190837056032]

Moist Heat or Steam Sterilization

[00190837056032]

Moist Heat or Steam Sterilization

[00190837056032]

Moist Heat or Steam Sterilization

[00190837056032]

Moist Heat or Steam Sterilization

[00190837056032]

Moist Heat or Steam Sterilization

[00190837056032]

Moist Heat or Steam Sterilization

[00190837056032]

Moist Heat or Steam Sterilization

[00190837056032]

Moist Heat or Steam Sterilization

[00190837056032]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-14
Device Publish Date2019-11-06

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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