PRAGER SHELL® P106SVGS

GUDID B360PSVGS0

PRAGER SHELL® P106 AUTOCLAVABLE ULTRASOUND IMMERSION SHELL.

ESI CORPORATION

Eye cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash 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