Contour Healer

GUDID 00859598007041

Temporary analog for Nobel ™ Conical Connection Compatible 4.3/5.0 mm devices

CONTOUR HEALER, LLC

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID00859598007041
NIH Device Record Keya8069ccb-311d-4d4d-84cd-0a36aa5fa477
Commercial Distribution StatusIn Commercial Distribution
Brand NameContour Healer
Version Model NumberNobel ™ Conical Connection Compatible 4.3/5.0 mm
Company DUNS032086267
Company NameCONTOUR HEALER, LLC
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 Usetrue
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

Phone757-288-6671
Emailcontourhealer@gmail.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100859598007041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NAHSystem, Test, Tumor Marker, For Detection Of Bladder Cancer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00859598007041]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-12-07
Device Publish Date2018-09-07

On-Brand Devices [Contour Healer]

00859598007126Temporary analog for Nobel Replace 3.5mm
00859598007119Temporary analog for Hiossen Standard Connection Compatible device
00859598007102Temporary analog for Straumann Bone Level Compatible device
00859598007096Temporary analog for Biomet 3i ™ Compatible 5.0 mm device
00859598007089Temporary analog for Biomet 3i ™ Compatible 4.0 mm device
00859598007072Temporary analog for Zimmer ™ /BioHorizons ™ Compatible 5.7 mm device
00859598007065Temporary analog for Zimmer ™ /BioHorizons ™ Compatible 4.5 mm device
00859598007058Temporary analog for Zimmer ™ /BioHorizons ™ Compatible 3.5 mm device
00859598007041Temporary analog for Nobel ™ Conical Connection Compatible 4.3/5.0 mm devices
00859598007034Temporary analog for Nobel ™ Conical Connection Compatible 3.5 mm device
00859598007027Temporary analog for Nobel ™ Replace Compatible 5.0 mm Compatible device
00859598007010Temporary analog for Nobel ™ Replace Compatible 4.3 mm Compatible device
00859598007003Temporary analog for Nobel ™ Replace Compatible 3.5 mm Compatible device
90859598007136Straumann Bone Level Compatible RC
00859598007157Straumann RC Premolar
00859598007140Straumann Bone Level Compatible NC

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