Universal Plate Cutter

GUDID 00853190008895

JACE MEDICAL, LLC

Orthopaedic implantable-device cutter
Primary Device ID00853190008895
NIH Device Record Key95ffc96b-ca20-4772-bf75-e2d4e48e6a34
Commercial Distribution Discontinuation2026-05-20
Commercial Distribution StatusIn Commercial Distribution
Brand NameUniversal Plate Cutter
Version Model Number215.010.42
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
GS100853190008895 [Primary]

FDA Product Code

HXZCutter, Wire

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00853190008895]

Moist Heat or Steam Sterilization


[00853190008895]

Moist Heat or Steam Sterilization


[00853190008895]

Moist Heat or Steam Sterilization


[00853190008895]

Moist Heat or Steam Sterilization


[00853190008895]

Moist Heat or Steam Sterilization


[00853190008895]

Moist Heat or Steam Sterilization


[00853190008895]

Moist Heat or Steam Sterilization


[00853190008895]

Moist Heat or Steam Sterilization


[00853190008895]

Moist Heat or Steam Sterilization


[00853190008895]

Moist Heat or Steam Sterilization


[00853190008895]

Moist Heat or Steam Sterilization


[00853190008895]

Moist Heat or Steam Sterilization


[00853190008895]

Moist Heat or Steam Sterilization


[00853190008895]

Moist Heat or Steam Sterilization


[00853190008895]

Moist Heat or Steam Sterilization


[00853190008895]

Moist Heat or Steam Sterilization


[00853190008895]

Moist Heat or Steam Sterilization


[00853190008895]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-02-23
Device Publish Date2020-11-06

Devices Manufactured by JACE MEDICAL, LLC

00853190008895 - Universal Plate Cutter2024-02-23
00853190008895 - Universal Plate Cutter2024-02-23
00850051329014 - Sternalock EZ2023-11-28 Y Plate, 12 Holes, Narrow
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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