CHELSEA-EATON SPECULUM 508-354

GUDID 00192896044531

CHELSEA-EATON SPECULUM LARGE TUBE SLOTTED HANDLE

SONTEC INSTRUMENTS, INC.

Rectal speculum

• Primary Device ID: 00192896044531
• NIH Device Record Key: 01ee0289-7fed-4f5a-882a-0ebfc0cf91ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CHELSEA-EATON SPECULUM
• Version Model Number: 508-354
• Catalog Number: 508-354
• 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	00192896044531 [Primary]

FDA Product Code

• FFQ: SPECULUM, RECTAL

Sterilization

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

[00192896044531]

Dry Heat Sterilization;Moist Heat or Steam 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

On-Brand Devices [CHELSEA-EATON SPECULUM]

• 00192896044531: CHELSEA-EATON SPECULUM LARGE TUBE SLOTTED HANDLE
• 00192896120433: Chelsea-Eaton Speculum Small Size