omtmedical.comOMT LLC - "Neuro Pattie; 1/2"" - 1/4"" [W] x 2"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005663073 | 3005663073 | OMT, LLC | 1 | N | 2027-01-01 | 3848 SW 30th Ave Fort Lauderdale FL US 33312 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| M731K90019 | Spetzler Neuro Patties - "Neuro Pattie; 1/4"" [W] x 1/4"" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box" | 954-327-5687 | regulatory@omtmedical.com |
| M731K90049 | Spetzler Neuro Patties - "Neuro Pattie; 1/2"" - 1/4"" [W] x 3/8"" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box" | 954-327-5687 | regulatory@omtmedical.com |
| M731K90059 | Spetzler Neuro Patties - "Neuro Pattie; 1/2"" - 1/4"" [W] x 1"" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box" | 954-327-5687 | regulatory@omtmedical.com |
| M731K90069 | Spetzler Neuro Patties - "Neuro Pattie; 1/2"" - 1/4"" [W] x 2"" [L]; 0.35mm material thickness; Sterile; X-Ray detectable; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box" | 954-327-5687 | regulatory@omtmedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 66525 | 1691115705 | K172948 | |||
| 66525 | 1608350965 | K020736 | TRAATEK COTTONOID PATTIES | HBA | 2002-06-03 |
| 66525 | 1208991546 | ||||
| 66525 | 1284559095 | ||||
| 66525 | 1379100688 | ||||
| 66525 | 1469254991 | ||||
| 66525 | 1493328265 | ||||
| 66525 | 1787011492 | ||||
| 66525 | 1859684539 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HBA | 2 | 2002-06-03 |
GUDID#
OMT LLC - "Neuro Pattie; 1/2"" - 1/4"" [W] x 3"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Horizontal]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1/2"" - 1/4"" [W] x 3"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1/2"" - 1/4"" [W] x 4"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Horizontal]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1/2"" - 1/4"" [W] x 4"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 3/4"" - 1/4"" [W] x 1-1/2"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Horizontal]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 3/4"" - 1/4"" [W] x 1-1/2"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 3/4"" - 1/4"" [W] x 2"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Horizontal]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 3/4"" - 1/4"" [W] x 2"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 3/4"" - 1/4"" [W] x 2-/2"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Horizontal]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 3/4"" - 1/4"" [W] x 2-/2"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - L Series [Horizontal]
2025-12-31
OMT LLC - "Neuro Pattie; 3/4"" - 1/4"" [W] x 3"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1"" - 3/4"" [W] x 2"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Horizontal]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 10 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1"" - 3/4"" [W] x 2"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 10 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1"" - 3/4"" [W] x 3"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Horizontal]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 10 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1"" - 3/4"" [W] x 3"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 10 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1/8"" [W] x 1/8"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Horizontal]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1/8"" [W] x 1/8"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1/2"" [W] x 1/2"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Horizontal]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1/2"" [W] x 1/2"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 3/4"" [W] x 3/4"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Horizontal]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 3/4"" [W] x 3/4"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1/4"" [W] x 1-1/2"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Horizontal]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1/4"" [W] x 1-1/2"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1/4"" [W] x 3"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Horizontal]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1/4"" [W] x 3"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1/2"" [W] x 1"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Horizontal]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1/2"" [W] x 1"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1/2"" [W] x 1-1/2"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Horizontal]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1/2"" [W] x 1-1/2"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 20 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1/2"" [W] x 2"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Horizontal]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 10 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1/2"" [W] x 2"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 10 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1"" [W] x 1"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Horizontal]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 10 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1"" [W] x 1"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 10 Pouches/Box"
2025-12-31
OMT LLC - "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"
2025-12-31
OMT LLC - "Neuro Pattie; 1"" [W] x 1-1/2"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 10 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1/2"" [W] x 3"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Horizontal]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 10 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1/2"" [W] x 3"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Vertical]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 10 Pouches/Box"
2025-12-31
OMT LLC - "Neuro Pattie; 1"" [W] x 3"" [L]; 0.45mm material thickness; Sterile; X-Ray detectable [Horizontal]; Tissue Compatible Rayon; For Single Use; 10 Patties/Pouch; 10 Pouches/Box"
2025-12-31