| Primary Device ID | M731L9054H9 |
| NIH Device Record Key | c202cd42-5e84-41ca-a461-a68940c2806e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OMT LLC |
| Version Model Number | L Series [Horizontal] |
| Catalog Number | L-9054H |
| Company DUNS | 196899772 |
| Company Name | OMT, LLC |
| Device Count | 200 |
| 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 |
| Phone | 954-327-5687 |
| regulatory@omtmedical.com | |
| Phone | 954-327-5687 |
| regulatory@omtmedical.com | |
| Phone | 954-327-5687 |
| regulatory@omtmedical.com | |
| Phone | 954-327-5687 |
| regulatory@omtmedical.com | |
| Phone | 954-327-5687 |
| regulatory@omtmedical.com | |
| Phone | 954-327-5687 |
| regulatory@omtmedical.com | |
| Phone | 954-327-5687 |
| regulatory@omtmedical.com | |
| Phone | 954-327-5687 |
| regulatory@omtmedical.com | |
| Phone | 954-327-5687 |
| regulatory@omtmedical.com | |
| Phone | 954-327-5687 |
| regulatory@omtmedical.com | |
| Phone | 954-327-5687 |
| regulatory@omtmedical.com | |
| Phone | 954-327-5687 |
| regulatory@omtmedical.com |
| 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | 9054200 [Unit of Use] |
| HIBCC | M731L9054H9 [Primary] |
| HBA | Neurosurgical Paddie |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[M731L9054H9]
Ethylene Oxide
[M731L9054H9]
Ethylene Oxide
[M731L9054H9]
Ethylene Oxide
[M731L9054H9]
Ethylene Oxide
[M731L9054H9]
Ethylene Oxide
[M731L9054H9]
Ethylene Oxide
[M731L9054H9]
Ethylene Oxide
[M731L9054H9]
Ethylene Oxide
[M731L9054H9]
Ethylene Oxide
[M731L9054H9]
Ethylene Oxide
[M731L9054H9]
Ethylene Oxide
[M731L9054H9]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-08 |
| Device Publish Date | 2025-12-31 |
| 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 |