Ceramic Femoral Head

GUDID 04719886890846

BIOLOX® delta, Ø22mm, 12/14 Taper, Large, +5mm

UNITED ORTHOPEDIC CORP.

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Primary Device ID04719886890846
NIH Device Record Key1e05194e-525c-4972-a9bb-84bb8eae7fef
Commercial Distribution StatusIn Commercial Distribution
Brand NameCeramic Femoral Head
Version Model Number1203-5422
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
Emailtw.service@unitedorthopedic.com
Phone+886229294567
Emailtw.service@unitedorthopedic.com
Phone+886229294567
Emailtw.service@unitedorthopedic.com
Phone+886229294567
Emailtw.service@unitedorthopedic.com
Phone+886229294567
Emailtw.service@unitedorthopedic.com
Phone+886229294567
Emailtw.service@unitedorthopedic.com
Phone+886229294567
Emailtw.service@unitedorthopedic.com
Phone+886229294567
Emailtw.service@unitedorthopedic.com
Phone+886229294567
Emailtw.service@unitedorthopedic.com
Phone+886229294567
Emailtw.service@unitedorthopedic.com
Phone+886229294567
Emailtw.service@unitedorthopedic.com
Phone+886229294567
Emailtw.service@unitedorthopedic.com
Phone+886229294567
Emailtw.service@unitedorthopedic.com
Phone+886229294567
Emailtw.service@unitedorthopedic.com
Phone+886229294567
Emailtw.service@unitedorthopedic.com
Phone+886229294567
Emailtw.service@unitedorthopedic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104719886890846 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-22
Device Publish Date2022-11-14

On-Brand Devices [Ceramic Femoral Head]

04719886890846BIOLOX® delta, Ø22mm, 12/14 Taper, Large, +5mm
04719886890839BIOLOX® delta, Ø22mm, 12/14 Taper, Medium, +3mm
04719886890822BIOLOX® delta, Ø22mm, 12/14 Taper, Small, +1mm

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