Uni Tibial Tray WZ-1-1012

GUDID B046WZ110120

Uni Tibial Tray Size 2

SIGNAL MEDICAL CORPORATION

Coated unicondylar knee tibia prosthesis
Primary Device IDB046WZ110120
NIH Device Record Key62d46157-947b-4e6b-b431-3d7081e24bfd
Commercial Distribution StatusIn Commercial Distribution
Brand NameUni Tibial Tray
Version Model Number2
Catalog NumberWZ-1-1012
Company DUNS169289308
Company NameSIGNAL MEDICAL CORPORATION
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8103647070
Emailvfowler@signalmd.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB046WZ110120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-17
Device Publish Date2020-02-07

On-Brand Devices [Uni Tibial Tray]

B046WZ110150Uni Tibial Tray Size 5
B046WZ110140Uni Tibial Tray Size 4
B046WZ110130Uni Tibial Tray Size 3
B046WZ110120Uni Tibial Tray Size 2

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