PRAGER SHELL® P106SVGS

GUDID B360PSVGS0

PRAGER SHELL® P106 AUTOCLAVABLE ULTRASOUND IMMERSION SHELL.

ESI CORPORATION

Eye cup

• Primary Device ID: B360PSVGS0
• NIH Device Record Key: ca97eab7-d483-47dd-8ed8-bffe3cc6f732
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRAGER SHELL® P106SVGS
• Version Model Number: P106SV GOLD SERIES
• Company DUNS: 829391734
• Company Name: ESI CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 763-473-2533
• Email: sales@eyesurgin.com
• Phone: 763-473-2533
• Email: sales@eyesurgin.com
• Phone: 763-473-2533
• Email: sales@eyesurgin.com
• Phone: 763-473-2533
• Email: sales@eyesurgin.com
• Phone: 763-473-2533
• Email: sales@eyesurgin.com
• Phone: 763-473-2533
• Email: sales@eyesurgin.com
• Phone: 763-473-2533
• Email: sales@eyesurgin.com
• Phone: 763-473-2533
• Email: sales@eyesurgin.com
• Phone: 763-473-2533
• Email: sales@eyesurgin.com
• Phone: 763-473-2533
• Email: sales@eyesurgin.com

Device Dimensions

• Outer Diameter: 14 Millimeter
• Lumen/Inner Diameter: 12.2 Millimeter
• Outer Diameter: 14 Millimeter
• Lumen/Inner Diameter: 12.2 Millimeter
• Outer Diameter: 14 Millimeter
• Lumen/Inner Diameter: 12.2 Millimeter
• Outer Diameter: 14 Millimeter
• Lumen/Inner Diameter: 12.2 Millimeter
• Outer Diameter: 14 Millimeter
• Lumen/Inner Diameter: 12.2 Millimeter
• Outer Diameter: 14 Millimeter
• Lumen/Inner Diameter: 12.2 Millimeter
• Outer Diameter: 14 Millimeter
• Lumen/Inner Diameter: 12.2 Millimeter
• Outer Diameter: 14 Millimeter
• Lumen/Inner Diameter: 12.2 Millimeter
• Outer Diameter: 14 Millimeter
• Lumen/Inner Diameter: 12.2 Millimeter
• Outer Diameter: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B360PSVGS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082893

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[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 Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-26
• Device Publish Date: 2019-12-18

Devices Manufactured by ESI CORPORATION

• B360PSVGS0 - PRAGER SHELL® P106SVGS: 2019-12-26PRAGER SHELL® P106 AUTOCLAVABLE ULTRASOUND IMMERSION SHELL.
• B360PSVGS0 - PRAGER SHELL® P106SVGS: 2019-12-26 PRAGER SHELL® P106 AUTOCLAVABLE ULTRASOUND IMMERSION SHELL.
• B360011B12361 - Prager Ext Set A1236: 2019-12-11 Replacement Part
• B360011B12632 - Prager Ext Set B1263: 2019-12-11 Replacement Part
• B360KF100 - Kera-Flow: 2019-09-18 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