71352208

GUDID 03596010198020

TRIAL 12/14 TAPER FEMORAL HEAD 22MM + 8

Smith & Nephew, Inc.

Femoral head prosthesis trial
Primary Device ID03596010198020
NIH Device Record Key0ebef1d4-5763-4114-9085-642709ac32a1
Commercial Distribution StatusIn Commercial Distribution
Version Model Number71352208
Catalog Number71352208
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

Device Identifiers

Device Issuing AgencyDevice ID
GS103596010198020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010198020]

Moist Heat or Steam Sterilization


[03596010198020]

Moist Heat or Steam Sterilization


[03596010198020]

Moist Heat or Steam Sterilization


[03596010198020]

Moist Heat or Steam Sterilization


[03596010198020]

Moist Heat or Steam Sterilization


[03596010198020]

Moist Heat or Steam Sterilization


[03596010198020]

Moist Heat or Steam Sterilization


[03596010198020]

Moist Heat or Steam Sterilization


[03596010198020]

Moist Heat or Steam Sterilization


[03596010198020]

Moist Heat or Steam Sterilization


[03596010198020]

Moist Heat or Steam Sterilization


[03596010198020]

Moist Heat or Steam Sterilization


[03596010198020]

Moist Heat or Steam Sterilization


[03596010198020]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-01-31
Device Publish Date2015-08-30

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