75100851

GUDID 07611996121841

TRIAL FEMORAL HEAD 32 M/+4

Smith & Nephew, Inc.

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Primary Device ID07611996121841
NIH Device Record Key49cd86d1-9231-4d22-8270-78c096655b24
Commercial Distribution StatusIn Commercial Distribution
Version Model Number75100851
Catalog Number75100851
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
GS107611996121841 [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

[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

Moist Heat or Steam Sterilization


[07611996121841]

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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00885556747421 - FASTPAK2024-06-21 FASTPAK TIBIAL BASE TRIAL SIZE 3 RIGHT
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