MICROTEK

Basic Information

• Brand Name: MICROTEK
• Primary DI: 00748426090884
• Version / Model: 1
• Company Name: Microtek Medical Inc.
• Labeler DUNS: 106908437
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-17
• Public Version: 5
• Public Version Date: 2023-03-22
• Public Version Status: Update
• Public Device Record Key: 961940df-d4d3-478b-907c-fd60401e5552

Device Description

ACS FACE SHIELD ONLY

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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FYA	GOWN, SURGICAL	General, Plastic Surgery	878.4040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32292	Surgical helmet	A device worn by operating room personnel (the surgeon or assisting doctors/nurses) during a surgical procedure to protect them from the transfer of microorganisms, body fluids, and particulate material which may inadvertently come into contact or splash into their face. It is typically composed of a helmet frame with a transparent Plexiglas face shield. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50748426090889	GS1		10	In Commercial Distribution
Primary	00748426090884	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K102971	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store under normal warehouse conditions.