Medline-Microtek

Basic Information

• Brand Name: Medline-Microtek
• Primary DI: 20748426261967
• Version / Model: Probe Covers
• Catalog Number: 3787N
• Company Name: Microtek Medical LLC
• Labeler DUNS: 106908437
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2026-02-09
• Public Version: 1
• Public Version Date: 2026-02-17
• Public Version Status: New
• Public Device Record Key: 7a35505a-e01d-4bbd-acaf-5f66c1474631

Device Description

Intraoperative Probe Cover featuring IsoSilk™, 13 cm x 244 cm (5 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: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

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
Unit of Use	00748426261963	GS1
Primary	20748426261967	GS1

Customer Contacts

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