EVA Vitrectomy Pack Gravity Input 25G 8300.25G11

GUDID 08717872030708

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

Ophthalmic surgical procedure kit, non-medicated, single-use
Primary Device ID08717872030708
NIH Device Record Key48f25078-7098-4e8b-b9fa-18c898804c20
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVA Vitrectomy Pack Gravity Input 25G
Version Model Number8300.25G11
Catalog Number8300.25G11
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
GS108717872030708 [Primary]
GS118717872030705 [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 Gravity Input 25G]

087178720307088300.25G11
087178720190178300.25G01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.