EB-3000xyz

GUDID 00852194002007

HAI EB-3000xyz is the non-contact eyebank specular microscope which is used to evaluate the endothelial cells layer for human cornea. HAI EB-3000xyz used same design as the Bio-Optic Inc ( an UA manufacturer) It considered the device substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. That do not require approval of a premarket approval (PMA). According to the letter from FDA from FDA on April. 26, 2004.

Hightech American Industrial Labs Inc

Ophthalmic specular microscope
Primary Device ID00852194002007
NIH Device Record Key0cdffb9e-f581-459d-979c-b450e790229d
Commercial Distribution Discontinuation2025-12-25
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEB-3000xyz
Version Model Number1
Company DUNS961991916
Company NameHightech American Industrial Labs 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 Numberfalse
Manufacturing Datefalse
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
GS100852194002007 [Primary]

FDA Product Code

NQEMicroscope, Specular

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-02
Device Publish Date2025-12-25

Devices Manufactured by Hightech American Industrial Labs Inc

00852194002007 - EB-3000xyz2026-01-02HAI EB-3000xyz is the non-contact eyebank specular microscope which is used to evaluate the endothelial cells layer for human cornea. HAI EB-3000xyz used same design as the Bio-Optic Inc ( an UA manufacturer) It considered the device substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. That do not require approval of a premarket approval (PMA). According to the letter from FDA from FDA on April. 26, 2004.
00852194002007 - EB-3000xyz2026-01-02 HAI EB-3000xyz is the non-contact eyebank specular microscope which is used to evaluate the endothelial cells layer for human c
00852194002021 - EB-2000xyz2026-01-02 HAI EB-2000xyz is the non-contact eyebank specular microscope which is to be used to evaluate the endothelial cells layer for la
00852194002090 - HAI Caliper2025-12-24 Caliper, surgical instrument for ophthalmic use
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00852194002113 - HAI Specula2025-12-24 Specula, Surgical instrument for ophthalmic use
00852194002120 - HAI Spoon2025-12-24 Spoon, Surgical instrument for ophthalmic use
00852194002144 - HAI Spatula2025-12-24 Spatula, Surgical instrument for ophthalmic use
00852194002045 - HAI Scissisors2025-12-23 Scissors, surgical instruments for ophthalmic use
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