EVA TDC Vitrectomy Pack VGPC Input 25G 8310.25G02

GUDID 08717872030166

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

Ophthalmic surgical procedure kit, non-medicated, single-use
Primary Device ID08717872030166
NIH Device Record Key5e85db9e-30bf-4721-9c3b-10bc0a603e58
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVA TDC Vitrectomy Pack VGPC Input 25G
Version Model Number8310.25G02
Catalog Number8310.25G02
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
GS108717872030166 [Primary]
GS118717872030163 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQCUnit, Phacofragmentation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-22
Device Publish Date2020-04-14

On-Brand Devices [EVA TDC Vitrectomy Pack VGPC Input 25G]

087178720307778310.25G12
087178720210418310.25G02
087178720301668310.25G02
187178720346978310.25G12-00

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