MICROTEK

Basic Information

• Brand Name: MICROTEK
• Primary DI: 00748426086702
• 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: 2016-11-16
• Public Version: 4
• Public Version Date: 2023-03-22
• Public Version Status: Update
• Public Device Record Key: fccf76c9-d67c-4d82-9954-672cceb7e973

Device Description

SPECIAL PROCEDURES DRAPE W/MICROBAN, 86IN X 135IN, 1-EACH

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: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KKX	Drape, surgical	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47803	Reinforced laryngeal mask airway, single-use	A curved armoured tube with a distal inflatable cuff/mask intended to be used in inhalational anaesthesia and resuscitation to facilitate and secure airway patency for the delivery and exchange of gases in spontaneously breathing and ventilated patients. It is inserted into the hypopharynx above the glottis to create a seal and to prevent the tongue from obstructing the anatomical airway; it is wire reinforced to prevent kinking during patient movement. It may include a 15 mm connector, be radiopaque, and have a built-in pilot balloon for cuff pressure monitoring. It is available in various sizes/designs and is typically made of silicone/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	50748426086707	GS1		20	In Commercial Distribution
Primary	00748426086702	GS1

Customer Contacts

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

Storage Conditions

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