Biotrol

Basic Information

• Brand Name: Biotrol
• Primary DI: 00302730000030
• Version / Model: DOCW06-100
• Catalog Number: DOCW06-100
• 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: 47ca2c06-4cae-41d1-bc7d-9cc7b730e5f4

Device Description

OPTI-CIDE WIPES, 100 ct - Disinfectant (BIOTROL)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRJ	Disinfectant, medical devices	General Hospital	880.6890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58077	Medical device cleaning/disinfection wipe	A moist, pre-treated fabric intended to be used to wipe the surface of medical devices and equipment to clean and/or destroy harmful microorganisms or inhibit their activity. The fabric is impregnated with a solution that may include a detergent(s) for cleaning surfaces and/or a disinfectant agent(s) or a precursor compound that forms a disinfectant agent when activated (e.g., by a separate solution). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10302730000037	GS1	Tub - Canister	100	In Commercial Distribution
Primary	00302730000030	GS1
Package	20302730000034	GS1	Case	6	In Commercial Distribution

Customer Contacts

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