EVOLVE Proline

GUDID 00840420191373

WRIGHT MEDICAL TECHNOLOGY, INC.

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Primary Device ID00840420191373
NIH Device Record Keye0b40a80-edf0-414e-96e1-80eb2341661c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVOLVE Proline
Version Model Number2499S285
Company DUNS807201207
Company NameWRIGHT MEDICAL TECHNOLOGY, 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 Datetrue
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)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com
Phone+1(800)238-7117
Emailcustomerservice@wmt.com

Device Dimensions

Outer Diameter8.5 Millimeter
Device Size Text, specify0
Outer Diameter8.5 Millimeter
Device Size Text, specify0
Outer Diameter8.5 Millimeter
Device Size Text, specify0
Outer Diameter8.5 Millimeter
Device Size Text, specify0
Outer Diameter8.5 Millimeter
Device Size Text, specify0
Outer Diameter8.5 Millimeter
Device Size Text, specify0
Outer Diameter8.5 Millimeter
Device Size Text, specify0
Outer Diameter8.5 Millimeter
Device Size Text, specify0
Outer Diameter8.5 Millimeter
Device Size Text, specify0
Outer Diameter8.5 Millimeter
Device Size Text, specify0
Outer Diameter8.5 Millimeter
Device Size Text, specify0
Outer Diameter8.5 Millimeter
Device Size Text, specify0
Outer Diameter8.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840420191373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWTTEMPLATE
KWIPROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840420191373]

Moist Heat or Steam Sterilization


[00840420191373]

Moist Heat or Steam Sterilization


[00840420191373]

Moist Heat or Steam Sterilization


[00840420191373]

Moist Heat or Steam Sterilization


[00840420191373]

Moist Heat or Steam Sterilization


[00840420191373]

Moist Heat or Steam Sterilization


[00840420191373]

Moist Heat or Steam Sterilization


[00840420191373]

Moist Heat or Steam Sterilization


[00840420191373]

Moist Heat or Steam Sterilization


[00840420191373]

Moist Heat or Steam Sterilization


[00840420191373]

Moist Heat or Steam Sterilization


[00840420191373]

Moist Heat or Steam Sterilization


[00840420191373]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-02-07
Device Publish Date2016-09-17

On-Brand Devices [EVOLVE Proline]

008404201915642499H428
008404201915572499H426
008404201915402499H424
008404201915332499H422
008404201915262499H420
008404201915192499H418
008404201915022499S495
008404201914962499S485
008404201914892499S475
008404201914722499S465
008404201914652499S455
008404201914582499S445
008404201914412499H228
008404201914342499H226
008404201914272499H224
008404201914102499H222
008404201914032499H220
008404201913972499H218
008404201913802499S295
008404201913732499S285
008404201913662499S275
008404201913592499S265
008404201913422499S255
008404201913352499S245
0084042019132824981001
0084042019131124981002
0084042019130424981005
0084042019129824981003
0084042019128124987105
0084042019127424987100
0084042019126724982005
008404201912502499H028
008404201912432499H026
008404201912362499H024
008404201912292499H022
008404201912122499H020
008404201912052499H018
008404201911992499S095
008404201911822499S085
008404201911752499S075
008404201911682499S065
008404201911512499S055
008404201911442499S045
0084042019113724981009
0084042019112024981008
0084042019111324981007
0084042019110624987195
0084042019109024987185
0084042019108324987175
0084042019107624987165

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