27G Ultra Short Disposable 8000 CPM TDC cutter 8268.27S

GUDID 08717872031217

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

Ophthalmic surgical instrument handle, pneumatic
Primary Device ID08717872031217
NIH Device Record Key482ef8ad-a93c-41e4-bef9-d22221578bec
Commercial Distribution StatusIn Commercial Distribution
Brand Name27G Ultra Short Disposable 8000 CPM TDC cutter
Version Model Number8268.27S
Catalog Number8268.27S
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
GS108717872031217 [Primary]
GS118717872031214 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-19
Device Publish Date2019-06-04

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

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