20G Disposable phaco fragmentation needle, incl. wrench

GUDID 18717872033041

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

Phacoemulsification system handpiece tip, single-use
Primary Device ID18717872033041
NIH Device Record Key7528dccc-3a68-4d7f-9cb7-c86f2796d2e7
Commercial Distribution StatusIn Commercial Distribution
Brand Name20G Disposable phaco fragmentation needle, incl. wrench
Version Model Number8400.FT
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count3
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
GS108717872033044 [Primary]
GS118717872033041 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-20
Device Publish Date2021-05-12

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

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