PRAGER SHELL® P106SVGS

GUDID B360PSVGS0

PRAGER SHELL® P106 AUTOCLAVABLE ULTRASOUND IMMERSION SHELL.

ESI CORPORATION

Eye cup
Primary Device IDB360PSVGS0
NIH Device Record Keyca97eab7-d483-47dd-8ed8-bffe3cc6f732
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRAGER SHELL® P106SVGS
Version Model NumberP106SV GOLD SERIES
Company DUNS829391734
Company NameESI CORPORATION
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
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

Device Dimensions

Outer Diameter14 Millimeter
Lumen/Inner Diameter12.2 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter12.2 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter12.2 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter12.2 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter12.2 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter12.2 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter12.2 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter12.2 Millimeter
Outer Diameter14 Millimeter
Lumen/Inner Diameter12.2 Millimeter
Outer Diameter14 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB360PSVGS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITXTransducer, Ultrasonic, Diagnostic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B360PSVGS0]

Moist Heat or Steam Sterilization


[B360PSVGS0]

Moist Heat or Steam Sterilization


[B360PSVGS0]

Moist Heat or Steam Sterilization


[B360PSVGS0]

Moist Heat or Steam Sterilization


[B360PSVGS0]

Moist Heat or Steam Sterilization


[B360PSVGS0]

Moist Heat or Steam Sterilization


[B360PSVGS0]

Moist Heat or Steam Sterilization


[B360PSVGS0]

Moist Heat or Steam Sterilization


[B360PSVGS0]

Moist Heat or Steam Sterilization


[B360PSVGS0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-26
Device Publish Date2019-12-18

Devices Manufactured by ESI CORPORATION

B360PSVGS0 - PRAGER SHELL® P106SVGS2019-12-26PRAGER SHELL® P106 AUTOCLAVABLE ULTRASOUND IMMERSION SHELL.
B360PSVGS0 - PRAGER SHELL® P106SVGS2019-12-26 PRAGER SHELL® P106 AUTOCLAVABLE ULTRASOUND IMMERSION SHELL.
B360011B12361 - Prager Ext Set A12362019-12-11 Replacement Part
B360011B12632 - Prager Ext Set B12632019-12-11 Replacement Part
B360KF100 - Kera-Flow2019-09-18 Eye Irrigation Device
B360CS2001 - ClearScan®2018-07-06 ClearScan
B360P1000 - Prager Shell®2018-07-06 Accutome / MicroMedical
B360P100AS0 - Prager Shell®2018-07-06 Accutome Probe, Auto Stop
B360P1010 - Prager Shell®2018-07-06 For DGH 2009 and earlier

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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