Nautilus CA 116-233

GUDID 00190837091064

Awl, No Stop

Life Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00190837091064
NIH Device Record Key813d4bf2-62b6-41f3-bec9-fc9dfab5c398
Commercial Distribution StatusIn Commercial Distribution
Brand NameNautilus CA
Version Model Number116-233
Catalog Number116-233
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
GS100190837091064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837091064]

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 CA]

00190837087210Hexalobe T-25 Driver Shaft, 1/4", Cannulated
00190837091088Lenke Style Curved Probe
00190837091071Awl, With Stop
00190837091064Awl, No Stop

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.