GUDID 00840420198808

WRIGHT MEDICAL TECHNOLOGY, INC.

Surgical implant template, reusable
Primary Device ID00840420198808
NIH Device Record Key405b5f21-e181-4823-8fb5-726b519f5bc0
Commercial Distribution StatusIn Commercial Distribution
Version Model Number4940125
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100840420198808 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWIPROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840420198808]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-09-17

Devices Manufactured by WRIGHT MEDICAL TECHNOLOGY, INC.

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00889797111515 - Incompass Total Ankle System2025-09-08 Trial Tibial Tray Pegged
00889797111522 - Incompass Total Ankle System2025-09-08 Trial Tibial Tray Pegged
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00889797111546 - Incompass Total Ankle System2025-09-08 Trial Tibial Tray Pegged

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