EN100 TL HANDLE Z-874.01.000

GUDID 00192896088092

EN100 TL HANDLE

SONTEC INSTRUMENTS, INC.

General physical examination set

• Primary Device ID: 00192896088092
• NIH Device Record Key: 2e7c968d-29f7-4b57-a643-dd2d50a6de4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EN100 TL HANDLE
• Version Model Number: Z-874.01.000
• Catalog Number: Z-874.01.000
• 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	00192896088092 [Primary]

FDA Product Code

• ETF: UNIT, EXAMINING/TREATMENT, ENT

Sterilization

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

[00192896088092]

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: 2018-10-18
• Device Publish Date: 2018-09-17

Devices Manufactured by SONTEC INSTRUMENTS, INC.

• 00192896121669 - Castroviejo Needle Holder: 2025-07-09 Castroviejo Needle Holder Round Handle Tungsten Carbide Curved Without Lock Streamlined
• 00192896121676 - Periodontal Probe: 2025-07-09 Periodontal Probe #W Light Handle Single End Non Color Coded Williams
• 00192896121621 - Gelpi Retractor: 2025-06-25 Gelpi Retractor Deep Angle With Enclosed Ratchet 6.5 Inches
• 00192896121638 - Debakey Neonatal Clamp: 2025-06-25 Debakey Neonatal Clamp Medium Full Curved Jaw/Shank A
• 00192896121645 - Debakey Neonatal Clamp: 2025-06-25 Debakey Neonatal Clamp Double Angled 45 Degrees Jaw/Shank A
• 00192896121652 - Debakey Scissors: 2025-06-25 Debakey Scissors 45 Degree Angle Power Cut
• 00192896121362 - Barraquer Iris Spatula: 2025-06-16 Barraquer Iris Spatula Round Smooth Curved Blades
• 00192896121607 - Micasept Top Dur Needle Holder: 2025-06-16 Micasept Top Dur Needle Holder With Hegar Ratchet Curved 4.5 Millimeter Tip