U2™ Hip 1403-6458

GUDID 04719872168508

Acetabular cup liner trial, ID 28mm, 10°×58mm

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 ID04719872168508
NIH Device Record Key7fc046fb-77c4-4965-be24-93ae9279a9fe
Commercial Distribution StatusIn Commercial Distribution
Brand NameU2™ Hip
Version Model Number1403-6458
Catalog Number1403-6458
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
GS104719872168508 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04719872168508]

Moist Heat or Steam Sterilization

[04719872168508]

Moist Heat or Steam Sterilization

[04719872168508]

Moist Heat or Steam Sterilization

[04719872168508]

Moist Heat or Steam Sterilization

[04719872168508]

Moist Heat or Steam Sterilization

[04719872168508]

Moist Heat or Steam Sterilization

[04719872168508]

Moist Heat or Steam Sterilization

[04719872168508]

Moist Heat or Steam Sterilization

[04719872168508]

Moist Heat or Steam Sterilization

[04719872168508]

Moist Heat or Steam Sterilization

[04719872168508]

Moist Heat or Steam Sterilization

[04719872168508]

Moist Heat or Steam Sterilization

[04719872168508]

Moist Heat or Steam Sterilization

[04719872168508]

Moist Heat or Steam Sterilization

[04719872168508]

Moist Heat or Steam Sterilization

[04719872168508]

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 [U2™ Hip]

04719872179245U2 Cup liner impactor, I.D. 28mm
04719872179238U2 Cup liner impactor, I.D. 26mm
04719872179122Broach handle
04719872179115Neck trial, #0
04719872179108Stem impactor, long
04719872177876U2 XPE case
04719872173830Cup impactor, offset
04719872173816Cup reamer handle, offset
04719872173755Size plate, XPE hip
04719872173496Flexible drill, 50mm
04719872173472Flexible drill, 35mm
04719872173458Flexible drill, 25mm
04719872173434Flexible drill, 15mm
04719872173410Cup reamer, 70mm
04719872173403Cup reamer, 69mm
04719872173397Cup reamer, 68mm
04719872173380Cup reamer, 67mm
04719872173373Cup reamer, 66mm
04719872173366Cup reamer, 65mm
04719872173359Cup reamer, 64mm
04719872173342Cup reamer, 63mm
04719872173335Cup reamer, 62mm
04719872173328Cup reamer, 61mm
04719872173311Cup reamer, 60mm
04719872173304Cup reamer, 59mm
04719872173298Cup reamer, 58mm
04719872173281Cup reamer, 57mm
04719872173274Cup reamer, 56mm
04719872173267Cup reamer, 55mm
04719872173250Cup reamer, 54mm
04719872173243Cup reamer, 53mm
04719872173236Cup reamer, 52mm
04719872173229Cup reamer, 51mm
04719872173212Cup reamer, 50mm
04719872173205Cup reamer, 49mm
04719872173199Cup reamer, 48mm
04719872173182Cup reamer, 47mm
04719872173175Cup reamer, 46mm
04719872173168Cup reamer, 45mm
04719872173151Cup reamer, 44mm
04719872173144Cup reamer, 43mm
04719872173137Cup reamer, 42mm
04719872173120Cup reamer, 41mm
04719872173113Cup reamer, 40mm
04719872173106Cup reamer, 39mm
04719872173090Cup reamer, 38mm
04719872173083Cup reamer, 37mm
04719872173076Cup reamer, 36mm
04719872173069Cup locator block
04719872173052Full XPE cup positioner
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