ENFOCUS 2300 INTEGRATED OCT

GUDID 00857691006039

BIOPTIGEN, INC.

Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system Ophthalmic spectral-domain optical coherence tomography system
Primary Device ID00857691006039
NIH Device Record Key8eb09b93-4a17-46d0-a67d-537a476a6390
Commercial Distribution StatusIn Commercial Distribution
Brand NameENFOCUS 2300 INTEGRATED OCT
Version Model Number900C23550V5
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)595-1274
EmailIris.Pohl@leica-microsystems.com
Phone+1(919)595-1274
EmailIris.Pohl@leica-microsystems.com
Phone+1(919)595-1274
EmailIris.Pohl@leica-microsystems.com
Phone+1(919)595-1274
EmailIris.Pohl@leica-microsystems.com
Phone+1(919)595-1274
EmailIris.Pohl@leica-microsystems.com
Phone+1(919)595-1274
EmailIris.Pohl@leica-microsystems.com
Phone+1(919)595-1274
EmailIris.Pohl@leica-microsystems.com
Phone+1(919)595-1274
EmailIris.Pohl@leica-microsystems.com
Phone+1(919)595-1274
EmailIris.Pohl@leica-microsystems.com
Phone+1(919)595-1274
EmailIris.Pohl@leica-microsystems.com
Phone+1(919)595-1274
EmailIris.Pohl@leica-microsystems.com
Phone+1(919)595-1274
EmailIris.Pohl@leica-microsystems.com
Phone+1(919)595-1274
EmailIris.Pohl@leica-microsystems.com
Phone+1(919)595-1274
EmailIris.Pohl@leica-microsystems.com
Phone+1(919)595-1274
EmailIris.Pohl@leica-microsystems.com
Phone+1(919)595-1274
EmailIris.Pohl@leica-microsystems.com
Phone+1(919)595-1274
EmailIris.Pohl@leica-microsystems.com

Device Dimensions

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Operating and Storage Conditions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100857691006039 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-10
Device Publish Date2024-05-02

Devices Manufactured by BIOPTIGEN, INC.

00857691006039 - ENFOCUS 2300 INTEGRATED OCT2024-05-10
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
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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