Reconstruction Plate Bending Pliers

GUDID 00853190008109

JACE MEDICAL, LLC

Bone fixation plate pliers
Primary Device ID00853190008109
NIH Device Record Key44a02f86-9dbe-4604-acde-cf2504ffe8f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameReconstruction Plate Bending Pliers
Version Model Number215.010.35
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
GS100853190008109 [Primary]

FDA Product Code

HXPInstrument, Bending Or Contouring

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00853190008109]

Moist Heat or Steam Sterilization


[00853190008109]

Moist Heat or Steam Sterilization


[00853190008109]

Moist Heat or Steam Sterilization


[00853190008109]

Moist Heat or Steam Sterilization


[00853190008109]

Moist Heat or Steam Sterilization


[00853190008109]

Moist Heat or Steam Sterilization


[00853190008109]

Moist Heat or Steam Sterilization


[00853190008109]

Moist Heat or Steam Sterilization


[00853190008109]

Moist Heat or Steam Sterilization


[00853190008109]

Moist Heat or Steam Sterilization


[00853190008109]

Moist Heat or Steam Sterilization


[00853190008109]

Moist Heat or Steam Sterilization


[00853190008109]

Moist Heat or Steam Sterilization


[00853190008109]

Moist Heat or Steam Sterilization


[00853190008109]

Moist Heat or Steam Sterilization


[00853190008109]

Moist Heat or Steam Sterilization


[00853190008109]

Moist Heat or Steam Sterilization


[00853190008109]

Moist Heat or Steam Sterilization


[00853190008109]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-29
Device Publish Date2018-09-28

Devices Manufactured by JACE MEDICAL, LLC

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00850051329021 - Sternalock EZ2023-11-28 Y Plate, 12 Holes, Wide
00853190008352 - Sternalock EZ2023-11-28 V Plate, 8 Holes
00853190008512 - Sternalock EZ2023-11-28 V Plate, 4 Holes
00853190008529 - Sternalock EZ2023-11-28 H Plate, 6 Holes
00853190008635 - Sternalock EZ2023-11-28 Box Plate, 4 Holes
00853190008642 - Sternalock EZ2023-11-28 O Plate, 6 Hole

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