Biotrol

Basic Information

• Brand Name: Biotrol
• Primary DI: 00302730000078
• Version / Model: SE125SWH
• Catalog Number: SE125SWH
• Company Name: YOUNG DENTAL MANUFACTURING I, LLC
• Labeler DUNS: 006309355
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-16
• Public Version: 2
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: ca645a3f-4750-402b-896c-3ccadd615f42

Device Description

Biotrol Surgical Evacuation Tips, White, .16? (4mm), Autoclavable Aspiration Instrument

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
EHZ	Evacuator, oral cavity	Dental	872.6640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37434	Dental suction system cannula, single-use	A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10302730000075	GS1	Box	50	In Commercial Distribution
Primary	00302730000078	GS1
Package	20302730000072	GS1	Case	30	In Commercial Distribution

Customer Contacts

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