Disposable Pneumatic Vitrectome.(23 gauge / 0.6 mm)(working with 30 P.S.I., max. 1267.NMD06

GUDID 08717872001418

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

Ophthalmic surgical instrument handle, pneumatic
Primary Device ID08717872001418
NIH Device Record Keyd6a5fdf5-9e1f-4215-af9b-aa80d32b3dc5
Commercial Distribution Discontinuation2023-09-14
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDisposable Pneumatic Vitrectome.(23 gauge / 0.6 mm)(working with 30 P.S.I., max.
Version Model Number1267.NMD06
Catalog Number1267.NMD06
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
GS108717872001418 [Primary]
GS118717872001415 [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 Number5
Public Version Date2023-09-15
Device Publish Date2016-09-30

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