PCT

GUDID 00815101027487

Centinel Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00815101027487
NIH Device Record Keye597df50-73d7-4aa1-9d0f-5dfc4b88d86f
Commercial Distribution StatusIn Commercial Distribution
Brand NamePCT
Version Model NumberPCT0435200
Company DUNS949024850
Company NameCentinel 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
GS100815101027487 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815101027487]

Moist Heat or Steam Sterilization


[00815101027487]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-06

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00815101028231PCT07DC011
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00815101028194PCT07LC018
00815101028187PCT07LC017
00815101028170PCT07LC016
00815101028163PCT07LC015
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00815101028040PCT08FC026
00815101028033PCT08FC025
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00815101028019PCT08FC023
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00815101027999PCT0440240
00815101027982PCT0440235
00815101027975PCT0440230
00815101027968PCT0440225
00815101027951PCT0440220
00815101027944PCT0440215
00815101027937PCT0440210
00815101027920PCT0440205
00815101027913PCT0440200
00815101027906PCT0440195
00815101027890PCT0440190
00815101027883PCT0440185
00815101027876PCT0440180
00815101027869PCT0440175
00815101027852PCT0440170
00815101027845PCT0440165
00815101027838PCT0440160
00815101027821PCT0440155
00815101027814PCT0440150
00815101027807PCT0440145
00815101027791PCT0440140

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