Bipolar II™ 1503-4144

GUDID 04719872168577

U2 Bipolar trial, φ44mm, ID 28mm

UNITED ORTHOPEDIC CORP.

Acetabulum prosthesis trial, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable Acetabulum prosthesis trial, prefabricated, reusable
Primary Device ID04719872168577
NIH Device Record Key6e2fc165-9c54-4038-a9df-f2bb83bad9ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameBipolar II™
Version Model Number1503-4144
Catalog Number1503-4144
Company DUNS656700556
Company NameUNITED ORTHOPEDIC CORP.
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw
Phone+886229294567
Emailservice@uoc.com.tw

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104719872168577 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04719872168577]

Moist Heat or Steam Sterilization

[04719872168577]

Moist Heat or Steam Sterilization

[04719872168577]

Moist Heat or Steam Sterilization

[04719872168577]

Moist Heat or Steam Sterilization

[04719872168577]

Moist Heat or Steam Sterilization

[04719872168577]

Moist Heat or Steam Sterilization

[04719872168577]

Moist Heat or Steam Sterilization

[04719872168577]

Moist Heat or Steam Sterilization

[04719872168577]

Moist Heat or Steam Sterilization

[04719872168577]

Moist Heat or Steam Sterilization

[04719872168577]

Moist Heat or Steam Sterilization

[04719872168577]

Moist Heat or Steam Sterilization

[04719872168577]

Moist Heat or Steam Sterilization

[04719872168577]

Moist Heat or Steam Sterilization

[04719872168577]

Moist Heat or Steam Sterilization

[04719872168577]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-02-07
Device Publish Date2017-05-19

On-Brand Devices [Bipolar II™]

04719872179269U2 Bipolar Case
04719872179207Head remover, φ32mm
04719872178859U2 Bipolar trial, φ56mm, ID 32mm
04719872178842U2 Bipolar trial, φ55mm, ID 32mm
04719872178835U2 Bipolar trial, φ54mm, ID 32mm
04719872178828U2 Bipolar trial, φ53mm, ID 32mm
04719872178811U2 Bipolar trial, φ52mm, ID 32mm
04719872178804U2 Bipolar trial, φ51mm, ID 32mm
04719872178798U2 Bipolar trial, φ50mm, ID 32mm
04719872177883U2 Bipolar case
04719872173786U2 Bipolar Case
04719872173779Size plate,Bipolar II
04719872173762Size plate, Bipolar II
04719872173601Bipolar trial handle
04719872173526Head remover, φ28mm
04719872173519Head remover, φ26mm
04719872173502Head remover, Ø22mm
04719872168744U2 Bipolar trial, Ø42mm, ID 22mm
04719872168737U2 Bipolar trial, Ø41mm, ID 22mm
04719872168720U2 Bipolar trial, Ø40mm, ID 22mm
04719872168713U2 Bipolar trial, Ø39mm, ID 22mm
04719872168706U2 Bipolar trial, Ø38mm, ID 22mm
04719872168690U2 Bipolar trial, φ56mm, ID 28mm
04719872168683U2 Bipolar trial, φ55mm, ID 28mm
04719872168676U2 Bipolar trial, φ54mm, ID 28mm
04719872168669U2 Bipolar trial, φ53mm, ID 28mm
04719872168652U2 Bipolar trial, φ52mm, ID 28mm
04719872168645U2 Bipolar trial, φ51mm, ID 28mm
04719872168638U2 Bipolar trial, φ50mm, ID 28mm
04719872168621U2 Bipolar trial, φ49mm, ID 28mm
04719872168614U2 Bipolar trial, φ48mm, ID 28mm
04719872168607U2 Bipolar trial, φ47mm, ID 28mm
04719872168591U2 Bipolar trial, φ46mm, ID 28mm
04719872168584U2 Bipolar trial, φ45mm, ID 28mm
04719872168577U2 Bipolar trial, φ44mm, ID 28mm
04719872168560U2 Bipolar trial, φ43mm, ID 28mm
04719872168553U2 Bipolar trial, φ42mm, ID 26mm
04719872162261U2 Bipolar trial, φ41mm, ID 26mm
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.