Replacement SS attachments for Durette® IV (temporals only) (2 units)

GUDID 20697660002518

Replacement stainless-steel attachments for Durette IV (temporals only) (2 units)

Oculo-Plastik Inc

Epiocular radiation shield, reusable
Primary Device ID20697660002518
NIH Device Record Key2961a92f-5bf8-49c6-983a-3cb0df19c15d
Commercial Distribution StatusIn Commercial Distribution
Brand NameReplacement SS attachments for Durette® IV (temporals only) (2 units)
Version Model Number21-550T
Company DUNS257382580
Company NameOculo-Plastik Inc
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone514-381-3292
Emailsales@oculoplastik.com

Device Identifiers

Device Issuing AgencyDevice ID
GS120697660002518 [Primary]

FDA Product Code

IWSShield, Eye, Radiological

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[20697660002518]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-19
Device Publish Date2019-11-11

Devices Manufactured by Oculo-Plastik Inc

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