EVA TDC Vitrectomy Pack VGPC Input 27G, Ultra short

GUDID 08717872031422

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

Ophthalmic surgical procedure kit, non-medicated, single-use
Primary Device ID08717872031422
NIH Device Record Key73bd33b4-cc8c-4eb4-960b-fd4f0579ee4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVA TDC Vitrectomy Pack VGPC Input 27G, Ultra short
Version Model Number8310.27S12
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
GS108717872031422 [Primary]
GS118717872031429 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-27
Device Publish Date2020-01-17

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

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