NEGUS MOUTH GAG HANDLE 485-520

GUDID 00192896087996

NEGUS MOUTH GAG HANDLE

SONTEC INSTRUMENTS, INC.

Mouth gag, adjustable, reusable

• Primary Device ID: 00192896087996
• NIH Device Record Key: dde80a32-cba1-4929-a62b-4d93b06660e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEGUS MOUTH GAG HANDLE
• Version Model Number: 485-520
• Catalog Number: 485-520
• 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	00192896087996 [Primary]

FDA Product Code

• LRC: INSTRUMENT, ENT MANUAL SURGICAL

Sterilization

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

[00192896087996]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-10-22
• Device Publish Date: 2018-09-17

Devices Manufactured by SONTEC INSTRUMENTS, INC.

• 00192896117594 - Sontec Kerrison Rongeur: 2024-05-21 Sontec Kerrison Rongeur Without Eject Pin 40° Forward Up-Angled Bite
• 00192896117600 - Reduction Forceps: 2024-05-21 Crab Claw Self Locking Reduction Forceps Pointed Tips Curved
• 00192896117617 - Reduction Forceps: 2024-05-21 Crab Claw Self Locking Reduction Forceps Curved
• 00192896117624 - Verbrugge Bone Clamp: 2024-05-21 Verbrugge Bone Clamp With Hybrid Lock Curved To Side
• 00192896117631 - Verbrugge Bone Clamp: 2024-05-21 Verbrugge Bone Clamp With Hybrid Lock Curved To Side
• 00192896117648 - Reduction Forceps: 2024-05-21 Crab Claw Self Locking Reduction Forceps Curved
• 00192896117549 - Debakey Retractor Frame: 2024-05-13 Debakey Retractor Frame 170 Millimeter Angled Arms
• 00192896117556 - Debakey Retractor Blades: 2024-05-13 Debakey Retractor Blades Adult