PIGALILEO/TC-PLUS/RT-PLUS 75009338

GUDID 07611996100525

PIGALILEO NAVIGATION PACKAGE SPEED-PINS 3.2 65 (6X)

Smith & Nephew, Inc.

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit
Primary Device ID07611996100525
NIH Device Record Keyc8bbda52-6e77-4483-81a7-0ecdddda5d33
Commercial Distribution StatusIn Commercial Distribution
Brand NamePIGALILEO/TC-PLUS/RT-PLUS
Version Model Number75009338
Catalog Number75009338
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS107611996100525 [Primary]

FDA Product Code

HTYPIN, FIXATION, SMOOTH

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


[07611996100525]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-11-13

On-Brand Devices [PIGALILEO/TC-PLUS/RT-PLUS]

07611996100549PIGALILEO NAVIGATION PACKAGE SPEED-PINS 3.2 110(6X)
07611996100532PIGALILEO NAVIGATION PACKAGE SPEED-PINS 3.2 80 (6X)
07611996100525PIGALILEO NAVIGATION PACKAGE SPEED-PINS 3.2 65 (6X)
07611996073270PIGALILEO TKR AO ADAPTER FOR SPEED-PIN

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