FDA.reportPublic FDA data

Prager Shell®

Primary DI
B360P1010
Brand
Prager Shell®
Company
ESI CORPORATION
Model
P-101
Catalog number
P-101
Device description
For DGH 2009 and earlier
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082893000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082893000PRAGER SHELLEsi, Inc.2008-12-05ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B360P1010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Eye cupA receptacle designed to fit around the eye socket and which is filled with warm water or an eyewash solution and placed over the eye to allow the liquid to wash the affected eye. It is typically used as a first line measure when dust or other particles have inadvertently entered the eye. It is usually made of plastic, glass or a ceramic material and is normally available [non-prescription] over-the-counter (OTC) for home-use, for use in the workplace, or for hospitalized or institutionalized patients. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter14Millimeter
Outer Diameter15.7Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
763-473-2533sales@eyesurgin.com

Regulatory Flags#

DUNS number
829391734
Device count
1
DM exempt
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B360CS2000ClearScan®CS200CS2002016-09-24
B360011B12360Prager Ext Set A1236011B1236011B12362016-09-24
B360011B12630Prager Ext Set B1263011B1263011B12632016-09-24
B360PSVGS0PRAGER SHELL® P106SVGSP106SV GOLD SERIES2019-12-18
B360P1000Prager Shell®P-100P-1002016-09-24
B360P100AS0Prager Shell®P-100-AS P-100-AS 2016-09-24
B360P10120Prager Shell®P-101-2 P-101-2 2016-09-24
B360P1020Prager Shell®P-102 P-102 2016-09-24
B360P10220Prager Shell®P-102-2 P-102-2 2016-09-24
B360P1030Prager Shell®P-103 P-103 2016-09-24
B360P103GS0Prager Shell®P-103GS P-103GS 2016-09-24
B360P103SV0Prager Shell®P-103SV P-103SV 2016-09-24
B360P1040Prager Shell®P-104 P-104 2016-09-24
B360P104GS0Prager Shell®P-104GS P-104GS 2016-09-24
B360P104SV0Prager Shell®P-104SV P-104SV 2016-09-24
B360P1050Prager Shell®P-105P-1052016-09-24
B360P1060Prager Shell®P-106 P-106 2016-09-24
B360P106GS0Prager Shell®P-106GS P-106GS 2016-09-24
B360P106SV0Prager Shell®P-106SV P-106SV 2016-09-24
B360P10720Prager Shell®P-107-2 P-107-2 2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701104600420T-LiteSONOSCANNERITX2026-08-25
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926365PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928468PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928628PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928703PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
04580826928956PENTAX MedicalPENTAX MEDICAL CORPORATIONITX2026-08-25
08800290029376CA2-13MSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036169PA2-9SSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800290036237BCC2-13SAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.ITX2026-08-18
00841517112684C5-1FUJIFILM SONOSITE, INC.ITX2026-08-07
00841436122078Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436122900Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436124294Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436125895Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126410Needle Guide BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27