EVA Vitrectomy Pack Gravity Input 20G 8300.20G01

GUDID 08717872018591

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

Ophthalmic surgical procedure kit, non-medicated, single-use
Primary Device ID08717872018591
NIH Device Record Key44dfa877-e41b-4ab1-a252-770e8cae1bfd
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVA Vitrectomy Pack Gravity Input 20G
Version Model Number8300.20G01
Catalog Number8300.20G01
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
GS108717872018591 [Primary]
GS118717872018598 [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 Number6
Public Version Date2020-03-19
Device Publish Date2016-09-23

On-Brand Devices [EVA Vitrectomy Pack Gravity Input 20G]

087178720306618300.20G11
087178720185918300.20G01

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