Prager Shell® P-101

GUDID B360P1010

For DGH 2009 and earlier

ESI CORPORATION

Eye cup

• Primary Device ID: B360P1010
• NIH Device Record Key: 44ab1071-5b38-4709-849c-268dbbcb589a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prager Shell®
• Version Model Number: P-101
• Catalog Number: P-101
• 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	B360P1010 [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