Medline-Microtek

Basic Information

• Brand Name: Medline-Microtek
• Primary DI: 10748426147523
• Version / Model: Probe Covers
• Catalog Number: PC1289PAN
• Company Name: Microtek Medical LLC
• Labeler DUNS: 106908437
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2026-01-22
• Public Version: 1
• Public Version Date: 2026-01-30
• Public Version Status: New
• Public Device Record Key: 43a4053c-d9f2-4389-acd8-1596baf26dbe

Device Description

General Purpose Probe Cover, 13 cm x 122 cm (5 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
Unit of Use	00748426147526	GS1
Primary	10748426147523	GS1

Customer Contacts

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