Microtek™

Basic Information

• Brand Name: Microtek™
• Primary DI: 00748426132423
• Version / Model: Probe Covers PC1292
• Catalog Number: PC1292
• Company Name: Microtek Medical LLC
• Labeler DUNS: 106908437
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-22
• Public Version: 1
• Public Version Date: 2025-12-30
• Public Version Status: New
• Public Device Record Key: 653f6ce6-6a7d-40a0-b7f0-18f13d02ddf7

Device Description

Intraoperative Probe Cover, 15 cm x 244 cm (6 in x 96 in)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44714	Intraoperative ultrasound imaging transducer cover	A sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used intraoperatively, e.g., on internal organs, during an ultrasound examination. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10748426132420	GS1	pack	20	In Commercial Distribution
Primary	00748426132423	GS1
Package	20748426132427	GS1	case	1	In Commercial Distribution

Customer Contacts

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