SWISS MODEL BLADE BREAKER HOLDER 11-4850

GUDID 00192896072404

SWISS MODEL BLADE BREAKER HOLDER SPHERICAL TIP

SONTEC INSTRUMENTS, INC.

Ophthalmic surgical instrument handle, manual

• Primary Device ID: 00192896072404
• NIH Device Record Key: aaa94ee6-3020-45d7-9493-4381836ef860
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SWISS MODEL BLADE BREAKER HOLDER
• Version Model Number: 11-4850
• Catalog Number: 11-4850
• Company DUNS: 040729840
• Company Name: SONTEC INSTRUMENTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: +1(800) 821-7496
• Email: info@sontecinstruments.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896072404 [Primary]

FDA Product Code

• EMF: KNIFE, SURGICAL
• GDZ: Handle, Scalpel

Sterilization

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

[00192896072404]

Dry Heat Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-05-08
• Device Publish Date: 2018-09-19

Devices Manufactured by SONTEC INSTRUMENTS, INC.

• 00192896118331 - Enucleation Scissors: 2024-08-15 Enucleation Scissors Medium Curve Blade Power Cut Gold
• 00192896118348 - Cottle Nasal Rasp: 2024-08-15 Cottle Nasal Rasp With Diamond Coating
• 00192896118355 - Aufricht Nasal Rasp: 2024-08-15 Aufricht Nasal Rasp With Diamond Coating
• 00192896118362 - Gruenwald Suction Forceps: 2024-08-15 Gruenwald Suction Forceps 45 Degree Upturned Through-Cutting 2 Millimeter Bite
• 00192896118379 - Fomon Nasal Rasp: 2024-08-15 Fomon Nasal Rasp Double-Ended With Diamond Coating
• 00192896118386 - Debakey Glover Vascular Clamp: 2024-08-15 Debakey Glover Vascular Clamp Straight Titanium
• 00192896118393 - Potts Smith Forceps: 2024-08-15 Potts Smith Forceps With Stop Pin & Dissector End Tungsten Carbide Serrated
• 00192896118409 - Gerald Forceps: 2024-08-15 Gerald Forceps With Stop Pin Without Platform Cross Serrated 1x2 Teeth Straight