Scleral Buckling Products: Style N/A, 2.5mm Oval Silicone Sleeve 92-35

GUDID 08717872014531

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

Scleral buckling device, non-bioabsorbable
Primary Device ID08717872014531
NIH Device Record Keyd9f04ff7-0d18-40da-a443-e8f7cb8b6f52
Commercial Distribution StatusIn Commercial Distribution
Brand NameScleral Buckling Products: Style N/A, 2.5mm Oval Silicone Sleeve
Version Model Number92-35
Catalog Number92-35
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
GS108717872014531 [Primary]
GS118717872014538 [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

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

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