75100849

GUDID 07611996121827

TRIAL FEMORAL HEAD 32 XS/-3

Smith & Nephew, Inc.

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Primary Device ID07611996121827
NIH Device Record Key6563a4e4-011d-4e34-98c1-8e9f832da7ba
Commercial Distribution StatusIn Commercial Distribution
Version Model Number75100849
Catalog Number75100849
Company DUNS109903521
Company NameSmith & Nephew, Inc.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com
Phone+1(800)821-5700
Emailgudid@smith-nephew.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107611996121827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


[07611996121827]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-31
Device Publish Date2015-08-29

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00885556918067 - Polar2024-04-18 POLAR CALCAR PLANER - 45MM
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00885556917978 - Legion2024-04-10 EM PROXIMAL GUIDE - L

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