23G Two Dimensional Cutter – 16k CPM 8278.VIT23

GUDID 18717872031948

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

Ophthalmic surgical instrument handle, pneumatic
Primary Device ID18717872031948
NIH Device Record Key6bf32499-7a6b-4d58-8ac9-5d62ee8a6e1e
Commercial Distribution StatusIn Commercial Distribution
Brand Name23G Two Dimensional Cutter – 16k CPM
Version Model Number8278.VIT23
Catalog Number8278.VIT23
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count6
DM Exemptfalse
Pre-market Exemptfalse
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
GS108717872031941 [Primary]
GS118717872031948 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-04
Device Publish Date2021-05-27

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

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