BELLOW WITH VENTIL AND CONNECTION

Basic Information

• Brand Name: BELLOW WITH VENTIL AND CONNECTION
• Primary DI: B0990411020100
• Version / Model: 04-11020-10
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-30
• Public Version: 5
• Public Version Date: 2018-09-20
• Public Version Status: Update
• Public Device Record Key: b281c18c-8db3-44b1-942f-55e613fe9556
• Distribution End Date: 2018-09-20

Device Description

BELLOW BLUE WITH VENTIL AND CONNECTION M8

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	884.1720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33466	ENT powder applicator	An applicator designed to utilize blowing air, typically through the use of a hand-operated bulb, to administer powdered medication to the ear, nose, or oral cavity/throat during an ear/nose/throat (ENT) procedure or treatment. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B0990411020100	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K002877	000