Prager Shell® P-105

GUDID B360P1050

Alcon OcuScan

ESI CORPORATION

Eye cup
Primary Device IDB360P1050
NIH Device Record Keydc08e286-adbd-4fa2-aaee-61ff0ad46b27
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrager Shell®
Version Model NumberP-105
Catalog NumberP-105
Company DUNS829391734
Company NameESI CORPORATION
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com
Phone763-473-2533
Emailsales@eyesurgin.com

Device Dimensions

Outer Diameter15.7 Millimeter
Lumen/Inner Diameter14 Millimeter
Outer Diameter15.7 Millimeter
Lumen/Inner Diameter14 Millimeter
Outer Diameter15.7 Millimeter
Lumen/Inner Diameter14 Millimeter
Outer Diameter15.7 Millimeter
Lumen/Inner Diameter14 Millimeter
Outer Diameter15.7 Millimeter
Lumen/Inner Diameter14 Millimeter
Outer Diameter15.7 Millimeter
Lumen/Inner Diameter14 Millimeter
Outer Diameter15.7 Millimeter
Lumen/Inner Diameter14 Millimeter
Outer Diameter15.7 Millimeter
Lumen/Inner Diameter14 Millimeter
Outer Diameter15.7 Millimeter
Lumen/Inner Diameter14 Millimeter
Outer Diameter15.7 Millimeter
Lumen/Inner Diameter14 Millimeter
Outer Diameter15.7 Millimeter
Lumen/Inner Diameter14 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB360P1050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Prager Shell®]

B360P110RXP0Alcon RXP OcuScan and UltraScan
B360P10720Nidek
B360P106SV0Ellex
B360P106GS0Ellex, Autoclavable Gold Series
B360P1060Ellex
B360P1050Alcon OcuScan
B360P104SV0Quantel Medical
B360P104GS0Quantel Medical, Autoclavable Gold Series
B360P1040Quantel Medical
B360P103SV0Sonomed
B360P103GS0Sonomed, Autoclavable
B360P1030Sonomed
B360P10220Tomey AL 4000
B360P1020Tomey AL 100
B360P10120For DGH 2010 and later
B360P1010For DGH 2009 and earlier
B360P100AS0Accutome Probe, Auto Stop
B360P1000Accutome / MicroMedical

Trademark Results [Prager Shell]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRAGER SHELL
PRAGER SHELL
76484587 2819198 Live/Registered
ESI, Corporation
2003-01-23

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