Paralleling Tool PAR

GUDID 10841307119142

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Dental implantation depth/angle gauge, reusable
Primary Device ID10841307119142
NIH Device Record Keyae02b2a5-a277-4a8b-bdd2-4a88c6338c52
Commercial Distribution StatusIn Commercial Distribution
Brand NameParalleling Tool
Version Model NumberPAR
Catalog NumberPAR
Company DUNS868856969
Company NameIMPLANT DIRECT SYBRON MANUFACTURING LLC
Device Count1
DM Exempttrue
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

Phone1-888-649-6425
Email[email protected]

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110841307119142 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10841307119142]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-27
Device Publish Date2015-12-29

Devices Manufactured by IMPLANT DIRECT SYBRON MANUFACTURING LLC

10841307119326 - RePlant® Laboratory Tool2019-11-27
10841307119319 - RePlant® Laboratory Tool2019-11-27
10841307119302 - RePlant® Laboratory Tool2019-11-27
10841307119296 - RePlant® Laboratory Tool2019-11-27
10841307119173 - ScrewRedirect® Guide Pin2019-11-27
10841307119166 - ScrewRedirect® Guide Pin2019-11-27
10841307119159 - ScrewRedirect® Guide Pin2019-11-27
10841307119142 - Paralleling Tool2019-11-27
10841307119142 - Paralleling Tool2019-11-27

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.