OMT LLC L-9059H

GUDID M731L9059H9

Neuro Pattie; 1" [W] x 1-1/2" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Horizontal]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 10 Pouches/Box

OMT, LLC

Cottonoid pad

Primary Device ID	M731L9059H9
NIH Device Record Key	f1f49f16-acb4-4cb3-997a-7d9244988c57
Commercial Distribution Status	In Commercial Distribution
Brand Name	OMT LLC
Version Model Number	L Series [Horizontal]
Catalog Number	L-9059H
Company DUNS	196899772
Company Name	OMT, LLC
Device Count	100
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	954-327-5687
Email	regulatory@omtmedical.com
Phone	954-327-5687
Email	regulatory@omtmedical.com
Phone	954-327-5687
Email	regulatory@omtmedical.com
Phone	954-327-5687
Email	regulatory@omtmedical.com
Phone	954-327-5687
Email	regulatory@omtmedical.com
Phone	954-327-5687
Email	regulatory@omtmedical.com
Phone	954-327-5687
Email	regulatory@omtmedical.com
Phone	954-327-5687
Email	regulatory@omtmedical.com
Phone	954-327-5687
Email	regulatory@omtmedical.com
Phone	954-327-5687
Email	regulatory@omtmedical.com
Phone	954-327-5687
Email	regulatory@omtmedical.com
Phone	954-327-5687
Email	regulatory@omtmedical.com

Operating and Storage Conditions

Storage Environment Temperature	Between 30 Degrees Fahrenheit and 70 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between 30 Degrees Fahrenheit and 70 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between 30 Degrees Fahrenheit and 70 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between 30 Degrees Fahrenheit and 70 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between 30 Degrees Fahrenheit and 70 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between 30 Degrees Fahrenheit and 70 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between 30 Degrees Fahrenheit and 70 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between 30 Degrees Fahrenheit and 70 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between 30 Degrees Fahrenheit and 70 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between 30 Degrees Fahrenheit and 70 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between 30 Degrees Fahrenheit and 70 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment Temperature	Between 30 Degrees Fahrenheit and 70 Degrees Fahrenheit
Storage Environment Humidity	Between 30 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	9059100 [Unit of Use]
HIBCC	M731L9059H9 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K020736

FDA Product Code

HBA	Neurosurgical Paddie

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2026-01-08
Device Publish Date	2025-12-31

On-Brand Devices [OMT LLC]

M731WT11100	Atraumatic-Malleable Disposable Suction; Sterile; 11 French [W]; 110mm [L]
M731WT09100	Atraumatic-Malleable Disposable Suction; Sterile; 9 French [W]; 110mm [L]
M731WT07100	Atraumatic-Malleable Disposable Suction; Sterile; 7 French [W]; 110mm [L]
M731RT15900	Atraumatic-Malleable Disposable Suction; Sterile; 15 French [W]; 190mm [L]
M731RT15800	Atraumatic-Malleable Disposable Suction; Sterile; 15 French [W]; 180mm [L]
M731RT15600	Atraumatic-Malleable Disposable Suction; Sterile; 15 French [W]; 160mm [L]
M731RT15400	Atraumatic-Malleable Disposable Suction; Sterile; 15 French [W]; 140mm [L]
M731RT15100	Atraumatic-Malleable Disposable Suction; Sterile; 15 French [W]; 110mm [L]
M731RT11900	Atraumatic-Malleable Disposable Suction; Sterile; 11 French [W]; 190mm [L]
M731RT11800	Atraumatic-Malleable Disposable Suction; Sterile; 11 French [W]; 180mm [L]
M731RT11600	Atraumatic-Malleable Disposable Suction; Sterile; 11 French [W]; 160mm [L]
M731RT11400	Atraumatic-Malleable Disposable Suction; Sterile; 11 French [W]; 140mm [L]
M731RT11100	Atraumatic-Malleable Disposable Suction; Sterile; 11 French [W]; 110mm [L]
M731RT09900	Atraumatic-Malleable Disposable Suction; Sterile; 9 French [W]; 190mm [L]
M731RT09800	Atraumatic-Malleable Disposable Suction; Sterile; 9 French [W]; 180mm [L]
M731RT09600	Atraumatic-Malleable Disposable Suction; Sterile; 9 French [W]; 160mm [L]
M731RT09400	Atraumatic-Malleable Disposable Suction; Sterile; 9 French [W]; 140mm [L]
M731RT09100	Atraumatic-Malleable Disposable Suction; Sterile; 9 French [W]; 110mm [L]
M731RT07900	Atraumatic-Malleable Disposable Suction; Sterile; 7 French [W]; 190mm [L]
M731RT07800	Atraumatic-Malleable Disposable Suction; Sterile; 7 French [W]; 180mm [L]
M731RT07600	Atraumatic-Malleable Disposable Suction; Sterile; 7 French [W]; 160mm [L]
M731RT07400	Atraumatic-Malleable Disposable Suction; Sterile; 7 French [W]; 140mm [L]
M731RT07100	Atraumatic-Malleable Disposable Suction; Sterile; 7 French [W]; 110mm [L]
M731RT05900	Atraumatic-Malleable Disposable Suction; Sterile; 5 French [W]; 190mm [L]
M731RT05800	Atraumatic-Malleable Disposable Suction; Sterile; 5 French [W]; 180mm [L]
M731RT05600	Atraumatic-Malleable Disposable Suction; Sterile; 5 French [W]; 160mm [L]
M731RT05400	Atraumatic-Malleable Disposable Suction; Sterile; 5 French [W]; 140mm [L]
M731RT05100	Atraumatic-Malleable Disposable Suction; Sterile; 5 French [W]; 110mm [L]
M731RT03900	Atraumatic-Malleable Disposable Suction; Sterile; 3 French [W]; 190mm [L]
M731RT03800	Atraumatic-Malleable Disposable Suction; Sterile; 3 French [W]; 180mm [L]
M731RT03600	Atraumatic-Malleable Disposable Suction; Sterile; 3 French [W]; 160mm [L]
M731RT03400	Atraumatic-Malleable Disposable Suction; Sterile; 3 French [W]; 140mm [L]
M731RT03100	Atraumatic-Malleable Disposable Suction; Sterile; 3 French [W]; 110mm [L]
M731FT11400	Atraumatic-Malleable Disposable Suction; Sterile; 11 French [W]; 140mm [L]
M731FT11100	Atraumatic-Malleable Disposable Suction; Sterile; 11 French [W]; 110mm [L]
M731FT09400	Atraumatic-Malleable Disposable Suction; Sterile; 9 French [W]; 140mm [L]
M731FT09100	Atraumatic-Malleable Disposable Suction; Sterile; 9 French [W]; 110mm [L]
M731FT07400	Atraumatic-Malleable Disposable Suction; Sterile; 7 French [W]; 140mm [L]
M731FT07100	Atraumatic-Malleable Disposable Suction; Sterile; 7 French [W]; 110mm [L]
M731V91329	Neuro Pattie; 3" - 2-3/4" [W] x 4" [L]; 0.35mm material thickness; Sterile; X-Ray detectable [V
M731V91309	Neuro Pattie; 2" - 1-3/4" [W] x 4" [L]; 0.35mm material thickness; Sterile; X-Ray detectable [V
M731V91069	Neuro Pattie; 1/8" [W] x 2-1/2" [L]; 0.35mm material thickness; Sterile; X-Ray detectable [Vert
M731V91049	Neuro Pattie; 1/8" [W] x 2" [L]; 0.35mm material thickness; Sterile; X-Ray detectable [Vertical
M731V91029	Neuro Pattie; 1/8" [W] x 1" [L]; 0.35mm material thickness; Sterile; X-Ray detectable [Vertical
M731V91009	Neuro Pattie; 1/8" [W] x 1/2" [L]; 0.35mm material thickness; Sterile; X-Ray detectable [Vertic
M731V90709	Neuro Pattie; 3" [W] x 6" [L]; 0.35mm material thickness; Sterile; X-Ray detectable [Vertical];
M731V90659	Neuro Pattie; 1" [W] x 3" [L]; 0.35mm material thickness; Sterile; X-Ray detectable [Vertical];
M731V90609	Neuro Pattie; 1/2" [W] x 3" [L]; 0.35mm material thickness; Sterile; X-Ray detectable [Vertical
M731V90559	Neuro Pattie; 1/2" [W] x 1" [L]; 0.35mm material thickness; Sterile; X-Ray detectable [Vertical
M731V90529	Neuro Pattie; 3/4" [W] x 3/4" [L]; 0.35mm material thickness; Sterile; X-Ray detectable [Vertic