PV GLIDESAFE HP & CABLE 10MM INTL (3 HP) P210HPD

GUDID 00841494105303

PV GLIDESAFE HP & CABLE 10MM INTL (3 HP)

Ellman International

Electrosurgical system

• Primary Device ID: 00841494105303
• NIH Device Record Key: cf32377a-f211-44ce-80d9-8d701c8d929b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PV GLIDESAFE HP & CABLE 10MM INTL (3 HP)
• Version Model Number: P210HPD
• Catalog Number: P210HPD
• 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	00841494105303 [Primary]
GS1	10841494105300 [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

Devices Manufactured by Ellman International

• 00841494102371 - CORNEAL SHIELD: 2019-05-23 CORNEAL SHIELD L(BLUE), 4 SHIELD, 1 HDLE
• 00841494102388 - CORNEAL SHIELD: 2019-05-23 CORNEAL SHIELD M(GREEN),4 SHIELD,1 HDLE
• 00841494102395 - CORNEAL SHIELD: 2019-05-23 CORNEAL SHIELD S(RED),4 SHIELDS,1 HANDLE
• 00841494102401 - CORNEAL SHIELDS: 2019-05-23 CORNEAL SHIELDS ASSORTED PACKAGE(S, M, L)
• 00841494104801 - SUCTION HANDLE: 2019-05-23 SUCTION HANDLE(25PCS)FOR CORNEAL SHIELDS
• 00841494104818 - SUCTION HANDLE FOR CORNEAL SHIELDS: 2019-05-23 SUCTION HANDLE(2PCS) FOR CORNEAL SHIELDS
• 00841494101015 - 1/8" PIN ELECTRODE: 2019-02-07 1/8" PIN ELECTRODE - 25 PCS STERILE
• 00841494101305 - Needle Electrode: 2019-02-07 3/4" STRAIGHT NEEDLE STERILE, SINGLE-USE