Spetzler Neuro Patties K-9070
GUDID M731K90709
Neuro Pattie; 3" [W] x 6" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box
OMT, LLC
Cottonoid pad| Primary Device ID | M731K90709 |
| NIH Device Record Key | 7dabcd5e-7a51-4925-b99f-cab70c097258 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spetzler Neuro Patties |
| Version Model Number | K Series |
| Catalog Number | K-9070 |
| Company DUNS | 196899772 |
| Company Name | OMT, LLC |
| Device Count | 30 |
| 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 |
| 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 |
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 | 9070030 [Unit of Use] |
| HIBCC | M731K90709 [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 [Spetzler Neuro Patties]
| M731K91329 | Neuro Pattie; 3" - 2-3/4" [W] x 4" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Ti |
| M731K91309 | Neuro Pattie; 2" - 1-3/4" [W] x 4" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Ti |
| M731K91069 | Neuro Pattie; 1/8" [W] x 2-1/2" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tissu |
| M731K91049 | Neuro Pattie; 1/8" [W] x 2" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tissue Co |
| M731K91029 | Neuro Pattie; 1/8" [W] x 1" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tissue Co |
| M731K91009 | Neuro Pattie; 1/8" [W] x 1/2" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tissue |
| M731K90719 | Neuro Pattie; 3" [W] x 4" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tissue Comp |
| M731K90709 | Neuro Pattie; 3" [W] x 6" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tissue Comp |
| M731K90659 | Neuro Pattie; 1" [W] x 3" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tissue Comp |
| M731K90609 | Neuro Pattie; 1/2" [W] x 3" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tissue Co |
| M731K90559 | Neuro Pattie; 1/2" [W] x 1" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tissue Co |
| M731K90529 | Neuro Pattie; 3/4" [W] x 3/4" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tissue |
| M731K90519 | Neuro Pattie; 1/2" [W] x 1/2" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tissue |
| M731K90509 | Neuro Pattie; 1/8" [W] x 1/8" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tissue |
| M731K90299 | Neuro Pattie; 1" - 3/4" [W] x 4" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tiss |
| M731K90289 | Neuro Pattie; 1" - 3/4" [W] x 3" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tiss |
| M731K90279 | Neuro Pattie; 1" - 3/4" [W] x 2" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tiss |
| M731K90269 | Neuro Pattie; 1" - 3/4" [W] x 1" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tiss |
| M731K90239 | Neuro Pattie; 3/4" - 1/4" [W] x 4" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Ti |
| M731K90229 | Neuro Pattie; 3/4" - 1/4" [W] x 3-1/2" [L]; 0.35mm material thickness; Sterile; X-Ray detectable |
| M731K90219 | Neuro Pattie; 3/4" - 1/4" [W] x 3" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Ti |
| M731K90209 | Neuro Pattie; 3/4" - 1/4" [W] x 2-/2" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; |
| M731K90199 | Neuro Pattie; 3/4" - 1/4" [W] x 2" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Ti |
| M731K90189 | Neuro Pattie; 3/4" - 1/4" [W] x 1-1/2" [L]; 0.35mm material thickness; Sterile; X-Ray detectable |
| M731K90179 | Neuro Pattie; 3/4" - 1/4" [W] x 1" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Ti |
| M731K90169 | Neuro Pattie; 3/4" - 1/4" [W] x 3/4" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; |
| M731K90159 | Neuro Pattie; 3/4" - 1/4" [W] x 3/8" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; |
| M731K90109 | Neuro Pattie; 1/2" - 1/4" [W] x 4" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Ti |
| M731K90099 | Neuro Pattie; 1/2" - 1/4" [W] x 3-1/2" [L]; 0.35mm material thickness; Sterile; X-Ray detectable |
| M731K90089 | Neuro Pattie; 1/2" - 1/4" [W] x 3" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Ti |
| M731K90079 | Neuro Pattie; 1/2" - 1/4" [W] x 2-1/2" [L]; 0.35mm material thickness; Sterile; X-Ray detectable |
| M731K90069 | Neuro Pattie; 1/2" - 1/4" [W] x 2" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Ti |
| M731K90059 | Neuro Pattie; 1/2" - 1/4" [W] x 1" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Ti |
| M731K90049 | Neuro Pattie; 1/2" - 1/4" [W] x 3/8" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; |
| M731K90019 | Neuro Pattie; 1/4" [W] x 1/4" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tissue |
Trademark Results [Spetzler Neuro Patties]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPETZLER NEURO PATTIES 78484113 not registered Dead/Abandoned |
OMT, LLC 2004-09-15 |
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