119657

GUDID 03596010057853

BLUNT MEDULLARY REAMER

Smith & Nephew, Inc.

Medullary canal orthopaedic reamer, rigid
Primary Device ID03596010057853
NIH Device Record Key4a539e56-fcf0-486e-b06a-e856854874b0
Commercial Distribution StatusIn Commercial Distribution
Version Model Number119657
Catalog Number119657
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
GS103596010057853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010057853]

Moist Heat or Steam Sterilization


[03596010057853]

Moist Heat or Steam Sterilization


[03596010057853]

Moist Heat or Steam Sterilization


[03596010057853]

Moist Heat or Steam Sterilization


[03596010057853]

Moist Heat or Steam Sterilization


[03596010057853]

Moist Heat or Steam Sterilization


[03596010057853]

Moist Heat or Steam Sterilization


[03596010057853]

Moist Heat or Steam Sterilization


[03596010057853]

Moist Heat or Steam Sterilization


[03596010057853]

Moist Heat or Steam Sterilization


[03596010057853]

Moist Heat or Steam Sterilization


[03596010057853]

Moist Heat or Steam Sterilization


[03596010057853]

Moist Heat or Steam Sterilization


[03596010057853]

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.

00885556920183 - R32024-11-21 Cup Medializer Tool
00885556920268 - Legion2024-11-21 Legion AP Block w/Cruciate Spikes - SZ 2
00885556817155 - INTELLIO 4K2024-11-19 INTELLIO 4K CCU NON-WIFI
00885556917442 - CORIOGRAPH2024-11-15 CORIOGRAPH PRE-OP PLANNING AND MODELING SERVICE
00885556919620 - R32024-11-14 R3 HEX ADAPTER
00885556919637 - R32024-11-14 MAGNETIC T-HANDLE SOCKET WRENCH
00885556919613 - R32024-11-12 OFFSET CUP IMPACTOR
00885556000908 - Legion2024-11-05 1 Degree Varus/Valgus Recut Block

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.