Phaco needle, 30°, Ø 0.9 mm, with white REF: 3003.S sleeve. 3005.FDS30

GUDID 08717872009124

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

Phacoemulsification system handpiece
Primary Device ID08717872009124
NIH Device Record Key300a381f-1940-4d10-abea-ce111a6f8fd1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePhaco needle, 30°, Ø 0.9 mm, with white REF: 3003.S sleeve.
Version Model Number3005.FDS30
Catalog Number3005.FDS30
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
GS108717872009124 [Primary]
GS118717872009121 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQCUnit, Phacofragmentation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08717872009124]

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

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