013642D

GUDID 00885556558768

REFURBREAR ENTRY AIMER-RIGHT

Smith & Nephew, Inc.

Orthopaedic implant aiming arm
Primary Device ID00885556558768
NIH Device Record Keyc8403f0a-f348-493b-b481-48c7a9cfdf12
Commercial Distribution StatusIn Commercial Distribution
Version Model Number013642D
Catalog Number013642D
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)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
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556558768 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


[00885556558768]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-22
Device Publish Date2017-09-21

Devices Manufactured by Smith & Nephew, Inc.

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00885556538401 - Legion2025-07-23 LEGION FINNED TIBIAL WEDGE SIZE4 15MM LEFT
00885556915875 - DIRECT VIEW AND VIDEO SCOPES2025-07-01 4KO VIDIOARTHROSCOPE AC 4 X 30 DEG X 160MM REVERSE POST
00885556915882 - DIRECT VIEW AND VIDEO SCOPE2025-07-01 4KO VIDEOARTHROSCOPE AC 4 X 70 DEG X 160MM REVERSE POST
00885556915899 - DIRECT VIEW AND VIDEO SCOPES2025-07-01 SERVICE REPLACEMENT 4KO VAS AC 4X 30 DEG X 160MM REVERSE POST
00885556915905 - DIRECT VIEW AND VIDEO SCOPE2025-07-01 SERVICE REPLACEMENT 4KO VAS AC 4 X 70 DEG X 160MM RND TIP REV POST
00885556900284 - TRIGEN MAX2025-06-10 TRIGEN MAX 13MM WASHER
00885556901960 - EVOS2025-06-02 EVOS PELVIC 2.7MM X 26MM CORTEX SCREW BLUNT TIP

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