EVA Vitrectomy Pack VGPC Input 20G 8300.20G12

GUDID 08717872030678

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

Ophthalmic surgical procedure kit, non-medicated, single-use
Primary Device ID08717872030678
NIH Device Record Key3cc86c5e-9f0b-49c0-963e-0e4fe7e88ee8
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVA Vitrectomy Pack VGPC Input 20G
Version Model Number8300.20G12
Catalog Number8300.20G12
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
GS108717872030678 [Primary]
GS118717872030675 [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 Number2
Public Version Date2019-11-08
Device Publish Date2019-10-04

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

087178720306788300.20G12
087178720189808300.20G02
187178720346598300.20G12-00

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