013597

GUDID 03596010091352

MTO AMR TIBIAL PUDDU

Smith & Nephew, Inc.

Orthopaedic implant aiming arm
Primary Device ID03596010091352
NIH Device Record Key0dedc453-5860-4546-8edf-e1752ece0a39
Commercial Distribution StatusIn Commercial Distribution
Version Model Number013597
Catalog Number013597
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
GS103596010091352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXARTHROSCOPE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03596010091352]

Moist Heat or Steam Sterilization


[03596010091352]

Moist Heat or Steam Sterilization


[03596010091352]

Moist Heat or Steam Sterilization


[03596010091352]

Moist Heat or Steam Sterilization


[03596010091352]

Moist Heat or Steam Sterilization


[03596010091352]

Moist Heat or Steam Sterilization


[03596010091352]

Moist Heat or Steam Sterilization


[03596010091352]

Moist Heat or Steam Sterilization


[03596010091352]

Moist Heat or Steam Sterilization


[03596010091352]

Moist Heat or Steam Sterilization


[03596010091352]

Moist Heat or Steam Sterilization


[03596010091352]

Moist Heat or Steam Sterilization


[03596010091352]

Moist Heat or Steam Sterilization


[03596010091352]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
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

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