Disposable keratoscope 1420.D

GUDID 18717872007400

D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Keratoscope, non-powered, single-use
Primary Device ID18717872007400
NIH Device Record Key1d389b25-8aff-4639-941f-08c2514378bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable keratoscope
Version Model Number1420.D
Catalog Number1420.D
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count6
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108717872007403 [Primary]
GS118717872007400 [Unit of Use]

FDA Product Code

HJAPhotokeratoscope

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-22
Device Publish Date2023-09-14

Devices Manufactured by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

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18717872034956 - 27G High Flow infusion line2024-02-29
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18717872035113 - EVA NEXUS™ Posterior 25G TDC Pack2024-02-29
18717872035120 - EVA NEXUS™ Posterior 27G TDC Pack2024-02-29
18717872035304 - EVA NEXUS™ Posterior 23G TDC Pack2024-02-29

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