Phaco needle, 30°, ø0.8 mm, with transparent REF: 3003.M sleeve. 3005.FDM30

GUDID 08717872009087

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

Phacoemulsification system handpiece
Primary Device ID08717872009087
NIH Device Record Key5737bf6f-cc4c-4011-b011-5513e3fee6a5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhaco needle, 30°, ø0.8 mm, with transparent REF: 3003.M sleeve.
Version Model Number3005.FDM30
Catalog Number3005.FDM30
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count3
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108717872009087 [Primary]
GS118717872009084 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQCUnit, Phacofragmentation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08717872009087]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-08
Device Publish Date2016-09-23

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

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