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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00885556921579 - LEGION2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 12MM
00885556921586 - LEGION2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 13MM
00885556921593 - LEGION2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 15MM
00885556921609 - LEGION2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 1-2 18MM
00885556921616 - LEGION2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 3-4 9MM
00885556921623 - LEGION2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 3-4 10MM
00885556921630 - LEGION2025-04-21 LEGION MEDIAL STABILIZED XLPE INSERT W/ JRNY LOCK RIGHT SZ 3-4 11MM

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