Prager Shell® P-102

GUDID B360P1020

Tomey AL 100

ESI CORPORATION

Eye cup 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: B360P1020
• NIH Device Record Key: 170baab3-1428-4cc5-bad4-e93d0a733448
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prager Shell®
• Version Model Number: P-102
• Catalog Number: P-102
• Company DUNS: 829391734
• Company Name: ESI CORPORATION
• Device Count: 1
• DM Exempt: true
• 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: true
• 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
• Phone: 763-473-2533
• Email: sales@eyesurgin.com

Device Dimensions

• Outer Diameter: 15.7 Millimeter
• Lumen/Inner Diameter: 14 Millimeter
• Outer Diameter: 15.7 Millimeter
• Lumen/Inner Diameter: 14 Millimeter
• Outer Diameter: 15.7 Millimeter
• Lumen/Inner Diameter: 14 Millimeter
• Outer Diameter: 15.7 Millimeter
• Lumen/Inner Diameter: 14 Millimeter
• Outer Diameter: 15.7 Millimeter
• Lumen/Inner Diameter: 14 Millimeter
• Outer Diameter: 15.7 Millimeter
• Lumen/Inner Diameter: 14 Millimeter
• Outer Diameter: 15.7 Millimeter
• Lumen/Inner Diameter: 14 Millimeter
• Outer Diameter: 15.7 Millimeter
• Lumen/Inner Diameter: 14 Millimeter
• Outer Diameter: 15.7 Millimeter
• Lumen/Inner Diameter: 14 Millimeter
• Outer Diameter: 15.7 Millimeter
• Lumen/Inner Diameter: 14 Millimeter
• Outer Diameter: 15.7 Millimeter
• Lumen/Inner Diameter: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B360P1020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082893

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Prager Shell®]

• B360P110RXP0: Alcon RXP OcuScan and UltraScan
• B360P10720: Nidek
• B360P106SV0: Ellex
• B360P106GS0: Ellex, Autoclavable Gold Series
• B360P1060: Ellex
• B360P1050: Alcon OcuScan
• B360P104SV0: Quantel Medical
• B360P104GS0: Quantel Medical, Autoclavable Gold Series
• B360P1040: Quantel Medical
• B360P103SV0: Sonomed
• B360P103GS0: Sonomed, Autoclavable
• B360P1030: Sonomed
• B360P10220: Tomey AL 4000
• B360P1020: Tomey AL 100
• B360P10120: For DGH 2010 and later
• B360P1010: For DGH 2009 and earlier
• B360P100AS0: Accutome Probe, Auto Stop
• B360P1000: Accutome / MicroMedical