SURGISTAR

GUDID 10878799008111

SURGISTAR, INC.

Surgical eye pressure shield
Primary Device ID10878799008111
NIH Device Record Key2dc7168e-b79f-4694-8849-ccca2e403758
Commercial Distribution StatusIn Commercial Distribution
Brand NameSURGISTAR
Version Model Number501044
Company DUNS808865125
Company NameSURGISTAR, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
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

Phone17605982480
EmailCUSTOMERSERVICE@SURGISTAR.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100878799008114 [Primary]
GS110878799008111 [Package]
Contains: 00878799008114
Package: [100 Units]
In Commercial Distribution

FDA Product Code

HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-02

On-Brand Devices [SURGISTAR]

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10878799009293881161
10878799009286885569
10878799009279885568
10878799009262885567

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