EVA Custom Vitrectomy Pack VGPC 23G 8523.211

GUDID 08717872021508

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

Ophthalmic surgical procedure kit, non-medicated, single-use
Primary Device ID08717872021508
NIH Device Record Key2b5d0db7-62d7-4661-99f6-d3dbd3a824c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVA Custom Vitrectomy Pack VGPC 23G
Version Model Number8523.211
Catalog Number8523.211
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
GS108717872021508 [Primary]
GS118717872021505 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQFLaser, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-08
Device Publish Date2016-09-30

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

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