Sentry Alif

GUDID 00190837021436

Life Spine, Inc.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID00190837021436
NIH Device Record Key99307e53-d6c7-4ca1-a1ef-a726ff4661ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameSentry Alif
Version Model Number169-050-36
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
GS100190837021436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837021436]

Moist Heat or Steam Sterilization


[00190837021436]

Moist Heat or Steam Sterilization


[00190837021436]

Moist Heat or Steam Sterilization


[00190837021436]

Moist Heat or Steam Sterilization


[00190837021436]

Moist Heat or Steam Sterilization


[00190837021436]

Moist Heat or Steam Sterilization


[00190837021436]

Moist Heat or Steam Sterilization


[00190837021436]

Moist Heat or Steam Sterilization


[00190837021436]

Moist Heat or Steam Sterilization


[00190837021436]

Moist Heat or Steam Sterilization


[00190837021436]

Moist Heat or Steam Sterilization


[00190837021436]

Moist Heat or Steam Sterilization


[00190837021436]

Moist Heat or Steam Sterilization


[00190837021436]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-12-08

On-Brand Devices [Sentry Alif]

00190837021481169-050-46
00190837021474169-050-44
00190837021467169-050-42
00190837021450169-050-40
00190837021443169-050-38
00190837021436169-050-36
00190837021429169-050-34
00190837021412169-050-32
00190837021405169-765-40
00190837021399169-765-35
00190837021382169-765-30
00190837021375169-765-25
00190837021368169-765-20
00190837021351169-755-40
00190837021344169-755-35
00190837021337169-755-30
00190837021320169-755-25
00190837021313169-755-20
00190837021306169-100-46
00190837021290169-100-44
00190837021283169-100-42
00190837021276169-100-40
00190837021269169-100-38
00190837021252169-100-36
00190837021245169-100-34
00190837021238169-100-32
001908370915212019-0082
001908370915142019-0081

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