27G Ultra Short Vitrectomy Kit 8310.27KS

GUDID 08717872031248

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

Ophthalmic surgical procedure kit, non-medicated, single-use
Primary Device ID08717872031248
NIH Device Record Key9065c37c-115d-4337-adb0-0a719ccde124
Commercial Distribution StatusIn Commercial Distribution
Brand Name27G Ultra Short Vitrectomy Kit
Version Model Number8310.27KS
Catalog Number8310.27KS
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
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 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
GS108717872031248 [Primary]

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 Number3
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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