PCT

GUDID 00815101023984

Centinel Spine, Inc.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00815101023984
NIH Device Record Keyf4a44c57-99d2-4a78-85b5-1e82e9d3c9e4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePCT
Version Model NumberPCT0135011
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
GS100815101023984 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00815101023984]

Moist Heat or Steam Sterilization


[00815101023984]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-27

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