Staight Plate, 4 Holes, Provisional

GUDID 00851599007792

JACE MEDICAL, LLC

Spinal implant trial
Primary Device ID00851599007792
NIH Device Record Key12c48751-7058-4b04-ad5c-67a37176e27d
Commercial Distribution StatusIn Commercial Distribution
Brand NameStaight Plate, 4 Holes, Provisional
Version Model Number215.411.04
Company DUNS063554875
Company NameJACE MEDICAL, LLC
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851599007792 [Primary]

FDA Product Code

PBFOrthopaedic Surgical Planning And Instrument Guides

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00851599007792]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-07
Device Publish Date2018-01-26

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