Phoropter VRx

GUDID 00812559011730

REICHERT, INC.

Diagnostic ophthalmic prism
Primary Device ID00812559011730
NIH Device Record Key598b7cf5-85d5-4aab-b377-be92b9aa3691
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhoropter VRx
Version Model Number16242
Company DUNS126650253
Company NameREICHERT, INC.
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812559011730 [Primary]

FDA Product Code

HKNRefractor, Manual, Non-Powered, Including Phoropter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-20
Device Publish Date2025-08-12

On-Brand Devices [Phoropter VRx]

0081255901173016242
0081255901171616241

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.