ENVISU C2300 VHR 220V

GUDID 00857691006053

BIOPTIGEN, INC.

Spectral-domain optical coherence tomography system
Primary Device ID00857691006053
NIH Device Record Keyc7bb3f34-5790-4c82-ab9c-390a2096f193
Commercial Distribution StatusIn Commercial Distribution
Brand NameENVISU C2300 VHR 220V
Version Model Number90-C2300-V1-220
Company DUNS361420040
Company NameBIOPTIGEN, INC.
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 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

Customer Support Contacts

Phone+1(919)3145500
Emailsupport@bioptigen.com

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *

Device Identifiers

Device Issuing AgencyDevice ID
GS100857691006053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBOTomography, optical coherence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-16

Devices Manufactured by BIOPTIGEN, INC.

00857691006039 - ENFOCUS 2300 INTEGRATED OCT2024-05-10
00857691006336 - ENFOCUS 2300 VHR 100V2020-12-01
00857691006343 - ENFOCUS 4400 VHR 100V2020-12-01
00857691006022 - ENVISU C2300 VHR 120V2018-07-06
00857691006053 - ENVISU C2300 VHR 220V2018-07-06
00857691006053 - ENVISU C2300 VHR 220V2018-07-06
00857691006084 - ENFOCUS C2300 VHR 120V2018-07-06
00857691006091 - ENFOCUS C2300 VHR 220V2018-07-06
00857691006107 - ENFOCUS C4400 HR 120V2018-07-06
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