PCD, VertaPlex 0507-586-000

GUDID 37613327357852

Precision System with Extension Tube and HV Bone Cement

STRYKER CORPORATION

Orthopaedic cement preparation/delivery kit
Primary Device ID37613327357852
NIH Device Record Key89db87b4-30bf-49ce-87d3-5b99a066f99d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePCD, VertaPlex
Version Model Number0507586000
Catalog Number0507-586-000
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
Phone+1(800)253-3210
EmailInst.Stryker.cs@stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@stryker.com
Phone+1(800)253-3210
EmailInst.Stryker.cs@stryker.com

Device Dimensions

Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree
Angle90 degree

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 24 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 24 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327357851 [Primary]
GS137613327357852 [Package]
Contains: 07613327357851
Package: pack [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Number5
Public Version Date2020-02-03
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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