OMT LLC

Basic Information

• Brand Name: OMT LLC
• Primary DI: M731L9021H9
• Version / Model: L Series [Horizontal]
• Company Name: OMT, LLC
• Labeler DUNS: 196899772
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2025-12-31
• Public Version: 1
• Public Version Date: 2026-01-08
• Public Version Status: New
• Public Device Record Key: 9f657816-b0f3-4a09-a14f-21d2613286f0

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HBA	Neurosurgical Paddie	Neurology	882.4700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32572	Cottonoid pad	A cushion-like mass made of cotton or man-made fibres used during surgery (e.g., neurosurgery) to protect tissue, absorb fluids, and/or stop bleeding. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M731L9021H9	HIBCC
Unit of Use	9021200	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K020736	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 30 – 70 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 30 – 60 Percent (%) Relative Humidity