Nautilus Spinal System

GUDID 00190837021733

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837021733
NIH Device Record Key1d462db6-413b-46fb-9a3d-7b19b50afc9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNautilus Spinal System
Version Model Number465-55-52
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 Usetrue
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
GS100190837021733 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837021733]

Moist Heat or Steam Sterilization

[00190837021733]

Moist Heat or Steam Sterilization

[00190837021733]

Moist Heat or Steam Sterilization

[00190837021733]

Moist Heat or Steam Sterilization

[00190837021733]

Moist Heat or Steam Sterilization

[00190837021733]

Moist Heat or Steam Sterilization

[00190837021733]

Moist Heat or Steam Sterilization

[00190837021733]

Moist Heat or Steam Sterilization

[00190837021733]

Moist Heat or Steam Sterilization

[00190837021733]

Moist Heat or Steam Sterilization

[00190837021733]

Moist Heat or Steam Sterilization

[00190837021733]

Moist Heat or Steam Sterilization

[00190837021733]

Moist Heat or Steam Sterilization

[00190837021733]

Moist Heat or Steam Sterilization

[00190837021733]

Moist Heat or Steam Sterilization

[00190837021733]

Moist Heat or Steam Sterilization

[00190837021733]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-06
Device Publish Date2018-07-05

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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