71362764

GUDID 03596010458353

REFLECTION REAMER DOME 64MM

Smith & Nephew, Inc.

Acetabular orthopaedic reamer
Primary Device ID03596010458353
NIH Device Record Key09e1b947-2e0a-4749-8e58-9654bdeb8d15
Commercial Distribution StatusIn Commercial Distribution
Version Model Number71362764
Catalog Number71362764
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
GS103596010458353 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDGProsthesis, hip, femoral component, cemented, metal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


[03596010458353]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-01-31
Device Publish Date2015-08-30

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00885556892640 - TRIGEN MAX2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 39CM LEFT
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00885556892664 - TRIGEN MAX2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 41CM LEFT
00885556892671 - TRIGEN MAX2025-05-19 TRIGEN MAX TIBIA NAIL 8MM X 42CM LEFT

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