UTF Hip Stem 9106-6312-RA

GUDID 04719872157014

UTF Broach, reduced, ML 0mm, #12

UNITED ORTHOPEDIC CORP.

Orthopaedic broach

Primary Device ID	04719872157014
NIH Device Record Key	341c5939-c761-4abe-af1e-07c4c12e975d
Commercial Distribution Status	In Commercial Distribution
Brand Name	UTF Hip Stem
Version Model Number	9106-6312-RA
Catalog Number	9106-6312-RA
Company DUNS	656700556
Company Name	UNITED ORTHOPEDIC CORP.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+886229294567
Email	service@uoc.com.tw

Device Dimensions

Device Size Text, specify

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872157014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K123550

FDA Product Code

LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[04719872157014]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-07-26
Device Publish Date	2018-06-25

On-Brand Devices [UTF Hip Stem]

04719872177814	UTF Broach, reduced, ML 0mm case
04719872177807	UTF Stem, reduced case #2
04719872177791	UTF Stem, reduced case #1
04719872177784	UTF Stem, reduced, case #1
04719872172758	UTF Stem, reduced, case #2
04719872172741	UTF Stem, reduced, case #1
04719872172734	UTF Stem, reduced case #1
04719872172710	UTF Stem, case #2
04719872172697	UTF Stem, case #1
04719872171232	UTF Neck trial, reduced, high offset, #0
04719872171188	UTF Neck trial, reduced, standard, #0~#00
04719872167594	UTF Broach, reduced, ML 0mm, #00
04719872167587	UTF Broach, reduced, #00
04719872167570	UTF Broach, reduced, ML 0mm, #13
04719872167549	UTF Broach, reduced, ML 0mm, #10
04719872167518	UTF Broach, reduced, ML 0mm, #8
04719872167495	UTF Broach, reduced, ML 0mm, #6
04719872167471	UTF Broach, reduced, ML 0mm, #5
04719872167457	UTF Broach, reduced, ML 0mm, #4
04719872167426	UTF Broach, reduced, ML 0mm, #2
04719872167402	UTF Broach, reduced, ML 0mm, #1
04719872167396	UTF Broach, reduced, #0
04719872157014	UTF Broach, reduced, ML 0mm, #12
04719872156994	UTF Broach, reduced, ML 0mm, #11
04719872156987	UTF Broach, reduced, ML 0mm, #9
04719872156970	UTF Broach, reduced, ML 0mm, #7
04719872156956	UTF Broach, reduced, ML 0mm, #3
04719872156932	UTF Broach, reduced, ML 0mm, #0
04719872156925	UTF Broach, #22
04719872156918	UTF Broach, #19
04719872156901	UTF Broach, #14.5
04719872156895	UTF Broach, #10
04719872156888	UTF Broach, #7.5
04711605584517	UTF Stem, reduced, case #1
04711605582445	Straight stem impactor
04711605582049	Curved stem impactor
04711605585330	Hip stem basic case
04711605585323	UTF-r case
04711605585316	Femoral cutting chisel, female
04711605585293	UTF Broach, female, reduced, ML 0mm, #14
04711605585286	UTF Broach, female, reduced, ML 0mm, #13
04711605585279	UTF Broach, female, reduced, ML 0mm, #12
04711605585262	UTF Broach, female, reduced, ML 0mm, #11
04711605585255	UTF Broach, female, reduced, ML 0mm, #10
04711605585248	UTF Broach, female, reduced, ML 0mm, #9
04711605585231	UTF Broach, female, reduced, ML 0mm, #8
04711605585224	UTF Broach, female, reduced, ML 0mm, #7
04711605585217	UTF Broach, female, reduced, ML 0mm, #6
04711605585200	UTF Broach, female, reduced, ML 0mm, #5
04711605585194	UTF Broach, female, reduced, ML 0mm, #4