417052

GUDID 03596010123633

REAMER T-HANDLE

Smith & Nephew, Inc.

Surgical instrument handle, non-torque-limiting
Primary Device ID03596010123633
NIH Device Record Key03f1585d-4329-4902-bb20-7ebe9899cd35
Commercial Distribution StatusIn Commercial Distribution
Version Model Number417052
Catalog Number417052
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

Device Identifiers

Device Issuing AgencyDevice ID
GS103596010123633 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDGProsthesis, hip, femoral component, cemented, metal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


[03596010123633]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-31
Device Publish Date2015-08-25

Devices Manufactured by Smith & Nephew, Inc.

00885556900284 - TRIGEN MAX2025-06-10 TRIGEN MAX 13MM WASHER
00885556901960 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 26MM CORTEX SCREW BLUNT TIP
00885556901977 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 28MM CORTEX SCREW BLUNT TIP
00885556901984 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 30MM CORTEX SCREW BLUNT TIP
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.