Disposable tubings complete with filter for air-fluid exchange 1250.ABD

GUDID 08717872000602

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

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Primary Device ID08717872000602
NIH Device Record Key424082b8-587e-491e-8f04-8124b8074bfe
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable tubings complete with filter for air-fluid exchange
Version Model Number1250.ABD
Catalog Number1250.ABD
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
GS108717872000602 [Primary]
GS118717872000609 [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 Date2020-03-18
Device Publish Date2016-09-23

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