Topographic Modeling System

GUDID 04582273603714

TOMEY CORPORATION.

Corneal topography system Corneal topography system Corneal topography system Corneal topography system Corneal topography system Corneal topography system Corneal topography system Corneal topography system Corneal topography system Corneal topography system Corneal topography system Corneal topography system Corneal topography system Corneal topography system Corneal topography system
Primary Device ID04582273603714
NIH Device Record Keyf5403843-6966-4d22-9aa7-0ca4e665c2ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameTopographic Modeling System
Version Model NumberTMS-4N
Company DUNS696280002
Company NameTOMEY CORPORATION.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104582273603714 [Primary]
GS104582273612129 [Previous]

FDA Product Code

MMQTopographer, Corneal, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-11
Device Publish Date2022-04-01

On-Brand Devices [Topographic Modeling System]

04582273612129with 31 cone
04582273612099100V
04582273603714TMS-4N

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