PV GLIDESAFE HP P215HPD

GUDID 00841494105310

PV GLIDESAFE HP & CABLE 15MM INTL (3 HP)

Ellman International

Electrosurgical system

• Primary Device ID: 00841494105310
• NIH Device Record Key: 5db0da62-5125-4256-b41e-0d67f69c4137
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PV GLIDESAFE HP
• Version Model Number: P215HPD
• Catalog Number: P215HPD
• Company DUNS: 079095245
• Company Name: Ellman International
• Device Count: 3
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841494105310 [Primary]
GS1	10841494105317 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102698

FDA Product Code

• GEI: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

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: 2016-09-21

On-Brand Devices [PV GLIDESAFE HP]

• 00841494105334: PV GLIDESAFE HP & CABLE 7.5MM INTL(3 HP)
• 00841494105327: PV GLIDESAFE HP & CABLE 20MM INTL (3 HP)
• 00841494105310: PV GLIDESAFE HP & CABLE 15MM INTL (3 HP)