EVA Vitrectomy Pack VGPC Input 27G 8300.27G02

GUDID 08717872019055

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

Ophthalmic surgical procedure kit, non-medicated, single-use
Primary Device ID08717872019055
NIH Device Record Keyd0f9b732-0a08-44e2-937d-524f401d61a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVA Vitrectomy Pack VGPC Input 27G
Version Model Number8300.27G02
Catalog Number8300.27G02
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
GS108717872019055 [Primary]
GS118717872019052 [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 StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-03-19
Device Publish Date2016-09-23

On-Brand Devices [EVA Vitrectomy Pack VGPC Input 27G]

087178720307398300.27G12
087178720190558300.27G02

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