U1 Hip System, Hip Stem, With Collar Porous Coated 1101-1040

GUDID 04712602340045

UNITED U1 Hip stem, porous coated, #4

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis
Primary Device ID04712602340045
NIH Device Record Keyb829c82b-d975-4e7b-983f-897781501b39
Commercial Distribution StatusIn Commercial Distribution
Brand NameU1 Hip System, Hip Stem, With Collar Porous Coated
Version Model Number1101-1040
Catalog Number1101-1040
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

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS104712602340045 [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, Hip Stem, With Collar Porous Coated]

04712602340083UNITED U1 Hip stem, porous coated, #7
04712602340076UNITED U1 Hip stem, porous coated, #6
04712602340069UNITED U1 Hip stem, porous coated, #5
04712602340052UNITED U1 Hip stem, porous coated, #4.5
04712602340045UNITED U1 Hip stem, porous coated, #4
04712602340038UNITED U1 Hip stem, porous coated, #3
04712602340021UNITED U1 Hip stem, porous coated, #2.5

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