Scleral Buckling Products: Style 507, 5.5mm x 7.5mm Oval Sponge 92-50-7.5

GUDID 08717872014685

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

Scleral buckling device, non-bioabsorbable
Primary Device ID08717872014685
NIH Device Record Key7dacdc48-9828-4407-8184-647b3565a0db
Commercial Distribution StatusIn Commercial Distribution
Brand NameScleral Buckling Products: Style 507, 5.5mm x 7.5mm Oval Sponge
Version Model Number92-50-7.5
Catalog Number92-50-7.5
Company DUNS407522184
Company NameD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Device Count1
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
GS108717872014685 [Primary]
GS118717872014682 [Package]
Package: box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQXImplant, Orbital, Extra-Ocular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2021-12-22
Device Publish Date2015-09-24

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