SURGITRON 4.0 DUAL RF 120 IEC3A-S30

GUDID 00841494104870

SURGITRON 4.0 DUAL RF/120 IEC

Ellman International

Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system Electrosurgical system

• Primary Device ID: 00841494104870
• NIH Device Record Key: 6ec75221-0d95-432d-9140-a5c896d7010f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURGITRON 4.0 DUAL RF 120
• Version Model Number: IEC3A-S30
• Catalog Number: IEC3A-S30
• Company DUNS: 079095245
• Company Name: Ellman International
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841494104870 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013255

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