SURGISTAR

GUDID 00878799009784

SURGISTAR, INC.

Corneal trephine, single-use
Primary Device ID00878799009784
NIH Device Record Key9d1df6a9-c653-4ffe-b5fb-7ebca7c0d374
Commercial Distribution StatusIn Commercial Distribution
Brand NameSURGISTAR
Version Model Number370775
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
GS100878799009784 [Primary]

FDA Product Code

HRHTrephine, Manual, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

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]

00878799009913330350
10878799009903965568
10878799009897965563
10878799009880184489
10878799009873184923
10878799009859185328
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00878799009784370775
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00878799009753370700
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00878799009456350650
10878799009293881161
10878799009286885569
10878799009279885568
10878799009262885567

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