MICROTEK

Basic Information

• Brand Name: MICROTEK
• Primary DI: 00748426090235
• 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: 2017-02-01
• Public Version: 3
• Public Version Date: 2023-03-22
• Public Version Status: Update
• Public Device Record Key: 37337c9d-3210-4aab-b947-77e0d7305583

Device Description

ANGIO DRAPE, 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
38369	Radiation shielding material, ionizing	A radiation protection device that attenuates ionizing radiation used to create barriers between an individual or a specific body part and a source of primary or scattered radiation used in medical or dental procedures. This group of devices includes a variety of materials, e.g., lead (Pb) bricks and sheets, lead-equivalent materials, leaded glass or plastic, tungsten (W), low molecular weight plastics or hydrogenous materials. Examples of use can be: lead bricks to build protective structures, lead sheets used in walls and doors, leaded glass or leaded-plastic sheets used in windows, mouldable lead-equivalent plastic or thermoplastic materials used to shield specific anatomical areas.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50748426090230	GS1		10	In Commercial Distribution
Primary	00748426090235	GS1

Customer Contacts

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

Storage Conditions

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