Legion Revision E0017153-3

GUDID 00885556797051

LEGION REVISION TRIAL SPACER - SZ 5-6

Smith & Nephew, Inc.

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Primary Device ID00885556797051
NIH Device Record Key2c5be223-d285-44cb-a425-1207b563e91e
Commercial Distribution StatusIn Commercial Distribution
Brand NameLegion Revision
Version Model NumberE0017153-3
Catalog NumberE0017153-3
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556797051 [Primary]
GS100885556797051 [Primary]
GS100885556797051 [Primary]
GS100885556797051 [Primary]
GS100885556797051 [Primary]
GS100885556797051 [Primary]
GS100885556797051 [Primary]
GS100885556797051 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556797051]

Moist Heat or Steam Sterilization


[00885556797051]

Moist Heat or Steam Sterilization


[00885556797051]

Moist Heat or Steam Sterilization


[00885556797051]

Moist Heat or Steam Sterilization


[00885556797051]

Moist Heat or Steam Sterilization


[00885556797051]

Moist Heat or Steam Sterilization


[00885556797051]

Moist Heat or Steam Sterilization


[00885556797051]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-30

On-Brand Devices [Legion Revision]

00885556734933AP HEMI-DISTAL SHIM - 15MM - SIZE 7-8R
00885556734926AP HEMI-DISTAL SHIM - 10MM - SIZE 7-8R
00885556734919AP HEMI-DISTAL SHIM - 5MM - SIZE 7-8R
00885556734902AP HEMI-DISTAL SHIM - 15MM - SIZE 5-6R
00885556734896AP HEMI-DISTAL SHIM - 10MM - SIZE 5-6R
00885556734889AP HEMI-DISTAL SHIM - 5MM - SIZE 5-6R
00885556734872AP HEMI-DISTAL SHIM - 15MM - SIZE 3-4R
00885556734865AP HEMI-DISTAL SHIM - 10MM - SIZE 3-4R
00885556734858AP HEMI-DISTAL SHIM - 5MM - SIZE 3-4R
00885556734841AP HEMI-DISTAL SHIM - 15MM - SIZE 7-8L
00885556734834AP HEMI-DISTAL SHIM - 10MM - SIZE 7-8L
00885556734827AP HEMI-DISTAL SHIM - 5MM - SIZE 7-8L
00885556734810AP HEMI-DISTAL SHIM - 15MM - SIZE 5-6L
00885556734803AP HEMI-DISTAL SHIM - 10MM - SIZE 5-6L
00885556734797AP HEMI-DISTAL SHIM - 5MM - SIZE 5-6L
00885556734780AP HEMI-DISTAL SHIM - 15MM - SIZE 3-4L
00885556734773AP HEMI-DISTAL SHIM - 10MM - SIZE 3-4L
00885556734766AP HEMI-DISTAL SHIM - 5MM - SIZE 3-4L
00885556734742AP HEMI-DISTAL SHIM - 15MM - SIZE 7-8R
00885556734735AP HEMI-DISTAL SHIM - 10MM - SIZE 7-8R
00885556734728AP HEMI-DISTAL SHIM - 5MM - SIZE 7-8R
00885556734711AP HEMI-DISTAL SHIM - 15MM - SIZE 5-6R
00885556734704AP HEMI-DISTAL SHIM - 10MM - SIZE 5-6R
00885556734698AP HEMI-DISTAL SHIM - 5MM - SIZE 5-6R
00885556734681AP HEMI-DISTAL SHIM - 15MM - SIZE 3-4R
00885556734674AP HEMI-DISTAL SHIM - 10MM - SIZE 3-4R
00885556734667AP HEMI-DISTAL SHIM - 5MM - SIZE 3-4R
00885556734650AP HEMI-DISTAL SHIM - 15MM - SIZE 7-8L
00885556734643AP HEMI-DISTAL SHIM - 10MM - SIZE 7-8L
00885556734636AP HEMI-DISTAL SHIM - 5MM - SIZE 7-8L
00885556734629AP HEMI-DISTAL SHIM - 15MM - SIZE 5-6L
00885556734612AP HEMI-DISTAL SHIM - 10MM - SIZE 5-6L
00885556734605AP HEMI-DISTAL SHIM - 5MM - SIZE 5-6L
00885556734599AP HEMI-DISTAL SHIM - 15MM - SIZE 3-4L
00885556734582AP HEMI-DISTAL SHIM - 10MM - SIZE 3-4L
00885556734575AP HEMI-DISTAL SHIM - 5MM - SIZE 3-4L
00885556734568AP HEMI-DISTAL SHIM - 15MM - SIZE 7-8R
00885556734551AP HEMI-DISTAL SHIM - 10MM - SIZE 7-8R
00885556734544AP HEMI-DISTAL SHIM - 5MM - SIZE 7-8R
00885556734537AP HEMI-DISTAL SHIM - 15MM - SIZE 5-6R
00885556734520AP HEMI-DISTAL SHIM - 10MM - SIZE 5-6R
00885556734513AP HEMI-DISTAL SHIM - 5MM - SIZE 5-6R
00885556734506AP HEMI-DISTAL SHIM - 15MM - SIZE 3-4R
00885556734490AP HEMI-DISTAL SHIM - 10MM - SIZE 3-4R
00885556734452AP HEMI-DISTAL SHIM - 5MM - SIZE 3-4R
00885556734445AP HEMI-DISTAL SHIM - 15MM - SIZE 7-8L
00885556734438AP HEMI-DISTAL SHIM - 10MM - SIZE 7-8L
00885556734421AP HEMI-DISTAL SHIM - 5MM - SIZE 7-8L
00885556734414AP HEMI-DISTAL SHIM - 15MM - SIZE 5-6L
00885556734407AP HEMI-DISTAL SHIM - 10MM - SIZE 5-6L

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