71369712

GUDID 03596010555588

MI TRIAL FEMORAL HEAD 28MM +12

Smith & Nephew, Inc.

Femoral head prosthesis trial
Primary Device ID03596010555588
NIH Device Record Keyba3ed59b-cdb7-4435-85ec-0e96e02f5244
Commercial Distribution StatusIn Commercial Distribution
Version Model Number71369712
Catalog Number71369712
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
GS103596010555588 [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

[03596010555588]

Moist Heat or Steam Sterilization


[03596010555588]

Moist Heat or Steam Sterilization


[03596010555588]

Moist Heat or Steam Sterilization


[03596010555588]

Moist Heat or Steam Sterilization


[03596010555588]

Moist Heat or Steam Sterilization


[03596010555588]

Moist Heat or Steam Sterilization


[03596010555588]

Moist Heat or Steam Sterilization


[03596010555588]

Moist Heat or Steam Sterilization


[03596010555588]

Moist Heat or Steam Sterilization


[03596010555588]

Moist Heat or Steam Sterilization


[03596010555588]

Moist Heat or Steam Sterilization


[03596010555588]

Moist Heat or Steam Sterilization


[03596010555588]

Moist Heat or Steam Sterilization


[03596010555588]

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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00885556921418 - Legion2024-12-04 Legion AP Cutting Block - Size 5
00885556921449 - Trigen2024-12-04 12.5mm Rigid Entry Reamer

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