CUSTOM TDC VITREC.PACK VGP 25G 8525.406-00

GUDID 18717872034710

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

Ophthalmic surgical procedure kit, non-medicated, single-use
Primary Device ID18717872034710
NIH Device Record Key19367609-31ff-4d00-bc52-16c40dba6161
Commercial Distribution Discontinuation2024-09-27
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCUSTOM TDC VITREC.PACK VGP 25G
Version Model Number8525.406-00
Catalog Number8525.406-00
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108717872034713 [Primary]
GS118717872034710 [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 Date2024-10-07
Device Publish Date2024-09-27

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

18717872034710 - CUSTOM TDC VITREC.PACK VGP 25G2024-10-07
18717872034710 - CUSTOM TDC VITREC.PACK VGP 25G2024-10-07
18717872034932 - 23G High Flow infusion line2024-02-29
18717872034949 - 25G High Flow infusion line2024-02-29
18717872034956 - 27G High Flow infusion line2024-02-29
18717872035106 - EVA NEXUS™ Posterior 23G TDC Pack2024-02-29
18717872035113 - EVA NEXUS™ Posterior 25G TDC Pack2024-02-29
18717872035120 - EVA NEXUS™ Posterior 27G TDC Pack2024-02-29
18717872035304 - EVA NEXUS™ Posterior 23G TDC Pack2024-02-29

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