71366519

GUDID 00885556110096

FEMORAL HEAD TRIAL 12/14 TAPER40 +8

Smith & Nephew, Inc.

Femoral head prosthesis trial
Primary Device ID00885556110096
NIH Device Record Keya866c656-6289-49b9-98cc-cca0a5ece7bf
Commercial Distribution StatusIn Commercial Distribution
Version Model Number71366519
Catalog Number71366519
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556110096 [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

[00885556110096]

Moist Heat or Steam Sterilization


[00885556110096]

Moist Heat or Steam Sterilization


[00885556110096]

Moist Heat or Steam Sterilization


[00885556110096]

Moist Heat or Steam Sterilization


[00885556110096]

Moist Heat or Steam Sterilization


[00885556110096]

Moist Heat or Steam Sterilization


[00885556110096]

Moist Heat or Steam Sterilization


[00885556110096]

Moist Heat or Steam Sterilization


[00885556110096]

Moist Heat or Steam Sterilization


[00885556110096]

Moist Heat or Steam Sterilization


[00885556110096]

Moist Heat or Steam Sterilization


[00885556110096]

Moist Heat or Steam Sterilization


[00885556110096]

Moist Heat or Steam Sterilization


[00885556110096]

Moist Heat or Steam Sterilization


[00885556110096]

Moist Heat or Steam Sterilization


[00885556110096]

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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00885556901991 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 32MM CORTEX SCREW BLUNT TIP
00885556902004 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 34MM CORTEX SCREW BLUNT TIP
00885556902011 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 36MM CORTEX SCREW BLUNT TIP
00885556902028 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 38MM CORTEX SCREW BLUNT TIP
00885556902035 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 40MM CORTEX SCREW BLUNT TIP

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