Microtek™

Basic Information

• Brand Name: Microtek™
• Primary DI: 00748426135806
• Version / Model: Probe Covers PC1290-1
• Catalog Number: PC1290
• Company Name: Microtek Medical LLC
• Labeler DUNS: 106908437
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-22
• Public Version: 2
• Public Version Date: 2026-02-12
• Public Version Status: Update
• Public Device Record Key: caf73e3e-e20b-436d-a938-825d9011b954
• Distribution End Date: 2026-02-11

Device Description

General Purpose Probe Cover, 15 cm x 122 cm (6 in x 48 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: No
• 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
44713	Body-surface ultrasound imaging transducer cover	A device/material 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 system imaging transducer (probe) used on the body surface 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	10748426135803	GS1	pack	20	Not in Commercial Distribution	2026-02-11
Primary	00748426135806	GS1
Package	20748426135800	GS1	case	1	Not in Commercial Distribution	2026-02-11

Customer Contacts

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