REUSABLE ELECTROSURGERY PUSH BUTTON PENCIL ESPR2

GUDID 00192896009431

REUSABLE ELECTROSURGERY PUSH BUTTON PENCIL

SONTEC INSTRUMENTS, INC.

Open-surgery electrosurgical electrode, monopolar, reusable

• Primary Device ID: 00192896009431
• NIH Device Record Key: 4233bfe0-21ca-4e66-8c13-db1bf7161467
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REUSABLE ELECTROSURGERY PUSH BUTTON PENCIL
• Version Model Number: ESPR2
• Catalog Number: ESPR2
• Company DUNS: 040729840
• Company Name: SONTEC INSTRUMENTS, INC.
• 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: 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

Customer Support Contacts

• Phone: 800-821-7496
• Email: info@sontecinstruments.com

Device Dimensions

• Length: 3 Meter
• Length: 3 Meter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896009431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984352

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[00192896009431]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-17
• Device Publish Date: 2018-08-16

Devices Manufactured by SONTEC INSTRUMENTS, INC.

• 00192896100671 - TEALE GORGET: 2025-03-04 TEALES GORGET SPECULUM TAPERED HALF MOON SHAPED PROBE ENDED BLADE ANGLED FLAT HANDLE
• 00192896121201 - Debakey Needle Pulling Forceps: 2025-03-04 Debakey Needle Pulling Forceps With Guide Pin Tungsten Carbide Serrated 3.5 Millimeter Tip
• 00192896121218 - Semken Tissue Forceps: 2025-03-04 Semken Tissue Forceps With Tungsten Carbide Serrated Platform 1x2 Teeth
• 00192896121225 - Sontec Dental Elevator Set: 2025-03-04 Sontec Dental Elevator Set Without Tray (10 each)
• 00192896121232 - Egress Cannula: 2025-03-04 Egress Cannula With Conical Obturator
• 00192896121249 - Beaver Chuck Handle: 2025-03-04 Beaver Chuck Handle Round #3K
• 00192896121157 - Stefan Miniature Bone Holding Forceps: 2025-02-25 Stefan Miniature Bone Holding Forceps Serrated Jaws With Long Ratchet Curved Tip Quantum
• 00192896121164 - Scalpel Blade Holder: 2025-02-25 Scalpel Blade Holder Safe-Ex 2 With Eject & Improved Function