Disposable Two step vitrectomy system. (23 gauge/ 0.6 mm) 1272.ED06

GUDID 18717872022380

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

Ophthalmic cannulation set, single-use
Primary Device ID18717872022380
NIH Device Record Key2a4c03a5-27d4-419f-916e-1a33b2f87e7a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Two step vitrectomy system. (23 gauge/ 0.6 mm)
Version Model Number1272.ED06
Catalog Number1272.ED06
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count5
DM Exemptfalse
Pre-market Exempttrue
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
GS108717872022383 [Primary]
GS118717872022380 [Unit of Use]

FDA Product Code

NGYCannula, Trocar, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-09
Device Publish Date2021-02-01

On-Brand Devices [Disposable Two step vitrectomy system. (23 gauge/ 0.6 mm)]

187178720223801272.ED06
187178720024361272.ED06

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