Nautilus Spinal System TNC65-35-5

GUDID 00190837058043

Non-Cannulated Screw, 6.5 x 35 Long

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837058043
NIH Device Record Key6cf8f892-6896-40be-97fd-afb0d03a4492
Commercial Distribution StatusIn Commercial Distribution
Brand NameNautilus Spinal System
Version Model NumberTNC65-35-5
Catalog NumberTNC65-35-5
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
GS100190837058043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837058043]

Moist Heat or Steam Sterilization

[00190837058043]

Moist Heat or Steam Sterilization

[00190837058043]

Moist Heat or Steam Sterilization

[00190837058043]

Moist Heat or Steam Sterilization

[00190837058043]

Moist Heat or Steam Sterilization

[00190837058043]

Moist Heat or Steam Sterilization

[00190837058043]

Moist Heat or Steam Sterilization

[00190837058043]

Moist Heat or Steam Sterilization

[00190837058043]

Moist Heat or Steam Sterilization

[00190837058043]

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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