U1 Hip System, Femoral Head 1201-1326

GUDID 04712602341479

U1 Hip System, Femoral head, OD 26mm,+3mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis
Primary Device ID04712602341479
NIH Device Record Keyc5356940-25fb-40a4-a879-e9991d5c84c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameU1 Hip System, Femoral Head
Version Model Number1201-1326
Catalog Number1201-1326
Company DUNS656700556
Company NameUNITED ORTHOPEDIC CORP.
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 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+886229294567
Emailservice@uoc.com.tw

Device Dimensions

Outer Diameter26 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS104712602341479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-02
Device Publish Date2015-10-24

On-Brand Devices [U1 Hip System, Femoral Head]

04712771497434U1 Hip System, Femoral head, OD 36mm, +7.5mm
04712771497427U1 Hip System, Femoral head, OD 36mm, +2.5mm
04712771497410U1 Hip System, Femoral head, OD 32mm, +7.5mm
04712771497403U1 Hip System, Femoral head, OD 32mm, +2.5mm
04712771497397U1 Hip System, Femoral head, OD 28mm, +7.5mm
04712771497380U1 Hip System, Femoral head, OD28mm, +2.5mm
04712771483109U1 Hip System, Femoral head, OD 36mm, +10mm
04712771483093U1 Hip System, Femoral head, OD 36mm, +5mm
04712771483086U1 Hip System, Femoral head, OD 36mm, +0mm
04712771483079U1 Hip System, Femoral head, OD 36mm, -3mm
04712771483062U1 Hip System, Femoral head, OD 32mm, +10mm
04712771483055U1 Hip System, Femoral head, OD 32mm, +5mm
04712771483048U1 Hip System, Femoral head, OD 32mm, +0mm
04712771483031U1 Hip System, Femoral head, OD 32mm, -3mm
04712602341554U1 Hip System, Femoral head, OD28mm, +10mm
04712602341547U1 Hip System, Femoral head, OD 26mm, +9mm
047126023415231201-1526
04712602341486U1 Hip System, Femoral head, OD28mm, +5mm
04712602341479U1 Hip System, Femoral head, OD 26mm,+3mm
04712602341431U1 Hip System, Femoral head, OD28mm, +0mm
04712602341424U1 Hip System, Femoral head, OD 26mm, +0mm
04712602341394U1 Hip System, Femoral head, OD28mm, -3mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.