71362747

GUDID 03596010456854

REFLECTION REAMER DOME 47MM

Smith & Nephew, Inc.

Acetabular orthopaedic reamer
Primary Device ID03596010456854
NIH Device Record Keyeb5c1dc4-9317-4cd5-a99f-dec6331f2ae8
Commercial Distribution StatusIn Commercial Distribution
Version Model Number71362747
Catalog Number71362747
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
GS103596010456854 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDGProsthesis, hip, femoral component, cemented, metal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

Moist Heat or Steam Sterilization


[03596010456854]

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

Devices Manufactured by Smith & Nephew, Inc.

00885556414965 - REFLECTION2025-12-11 REFLECTION XLPE 36MM INNER DIAMETER 0 DEGREE 54-56MM OUTER DIAMETER SIZE F ETO
00885556533574 - REFLECTION2025-12-11 REFLECTION XLPE 36MM INNER DIAMETER 0 DEGREE 66-68MM OUTER DIAMETER SIZE J ETO
00885556533581 - REFLECTION2025-12-11 REFLECTION XLPE 36MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F ETO
00885556535059 - REFLECTION2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE ANTEVERTED +4MM 50-52MM OUTER DIAMETER E ETO
00885556535073 - REFLECTION2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E ETO
00885556535080 - REFLECTION2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F ETO
00885556535097 - REFLECTION2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 58-60MM OUTER DIAMETERSIZE G ETO
00885556535103 - REFLECTION2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 62-64MM OUTER DIAMETER SIZE H ETO

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