Y Plate, 12 Holes, Narrow

GUDID 00853190008055

JACE MEDICAL, LLC

Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Primary Device ID00853190008055
NIH Device Record Key2fc4b53a-534e-44fa-aee5-dd9bed9cab56
Commercial Distribution StatusIn Commercial Distribution
Brand NameY Plate, 12 Holes, Narrow
Version Model Number115.504.12
Company DUNS063554875
Company NameJACE MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100853190008055 [Primary]

FDA Product Code

HRSPlate, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

Moist Heat or Steam Sterilization


[00853190008055]

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

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.