truTent 454391003

GUDID 00614950008575

truTent Tenting Screw 5mm Head, 1.5mm Thread, 14 MM Total Length

ACE SURGICAL SUPPLY CO., INC.

Dental implant suprastructure, permanent, preformed
Primary Device ID00614950008575
NIH Device Record Key9978d378-f89a-49cf-8cd0-329508980ede
Commercial Distribution StatusIn Commercial Distribution
Brand NametruTent
Version Model Number454391003
Catalog Number454391003
Company DUNS042763706
Company NameACE SURGICAL SUPPLY CO., INC.
Device Count1
DM Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)588-3100
Emailritaknight@acesurgical.com
Phone+1(508)588-3100
Emailritaknight@acesurgical.com

Device Dimensions

Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100614950008575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2016-12-01

On-Brand Devices [truTent]

00614950008575truTent Tenting Screw 5mm Head, 1.5mm Thread, 14 MM Total Length
00614950008568truTent Tenting Screw 5mm Head, 1.5mm Thread, 12 MM Total Length
00614950008551truTent Tenting Screw 5mm Head, 1.5mm Thread, 10 MM Total Length

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.