Nautilus Spinal System 1385-60-5

GUDID 00190837053932

Nautilus Polyaxial Screw CA, 8.5mm x 60mm Cannulated

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837053932
NIH Device Record Key867c200f-e3ae-4e8b-9ee7-2a73c388811c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNautilus Spinal System
Version Model Number1385-60-5
Catalog Number1385-60-5
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
GS100190837053932 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837053932]

Moist Heat or Steam Sterilization

[00190837053932]

Moist Heat or Steam Sterilization

[00190837053932]

Moist Heat or Steam Sterilization

[00190837053932]

Moist Heat or Steam Sterilization

[00190837053932]

Moist Heat or Steam Sterilization

[00190837053932]

Moist Heat or Steam Sterilization

[00190837053932]

Moist Heat or Steam Sterilization

[00190837053932]

Moist Heat or Steam Sterilization

[00190837053932]

Moist Heat or Steam Sterilization

[00190837053932]

Moist Heat or Steam Sterilization

[00190837053932]

Moist Heat or Steam Sterilization

[00190837053932]

Moist Heat or Steam Sterilization

[00190837053932]

Moist Heat or Steam Sterilization

[00190837053932]

Moist Heat or Steam Sterilization

[00190837053932]

Moist Heat or Steam Sterilization

[00190837053932]

Moist Heat or Steam Sterilization

[00190837053932]

Moist Heat or Steam Sterilization

[00190837053932]

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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