PCD, VertaPlex 0507-489-000

GUDID 37613327357845

Precision System with Short Extension Tube and Bone Cement

STRYKER CORPORATION

Orthopaedic cement preparation/delivery kit
Primary Device ID37613327357845
NIH Device Record Key18d3d000-e84a-4495-8752-82c5ebab7643
Commercial Distribution StatusIn Commercial Distribution
Brand NamePCD, VertaPlex
Version Model Number0507489000
Catalog Number0507-489-000
Company DUNS196548481
Company NameSTRYKER CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)253-3210
EmailInst.Stryker.cs@stryker.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327357844 [Primary]
GS137613327357845 [Package]
Contains: 07613327357844
Package: pack [4 Units]
In Commercial Distribution

FDA Product Code

NDNCEMENT, BONE, VERTEBROPLASTY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-05
Device Publish Date2017-04-21

On-Brand Devices [PCD, VertaPlex]

37613327357869Precision System with Extension Tube and Bone Cement
37613327357852Precision System with Extension Tube and HV Bone Cement
37613327357845Precision System with Short Extension Tube and Bone Cement
37613252018316Precision System Kit with Short Extension Tube and HV Bone Cement

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