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"
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| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3005663073 | 3005663073 | OMT, LLC | 1 | N | 2026-01-01 | 3848 SW 30th Ave Fort Lauderdale FL US 33312 |
| 3015536281 | 3015536281 | OMTMO LLC | 1 | Y | 2020-04-25 | 1732 1st Ave #306 New York NY US 10128 |
| 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 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 66525 | 1691115705 | K172948 | |||
| 231133 | 1438405682 | K103037 | IND URINARY TRACT INFECTION (UTI) TEST STRIPS | NGJ | 2012-04-17 |
| 66525 | 1608350965 | K020736 | TRAATEK COTTONOID PATTIES | HBA | 2002-06-03 |
| 231133 | 1113648648 | ||||
| 66525 | 1208991546 | ||||
| 231133 | 1230630327 | ||||
| 231133 | 1262812348 | ||||
| 66525 | 1284559095 | ||||
| 231133 | 1299978886 | ||||
| 66525 | 1379100688 | ||||
| 231133 | 1445164290 | ||||
| 66525 | 1469254991 | ||||
| 66525 | 1493328265 | ||||
| 66525 | 1787011492 | ||||
| 66525 | 1859684539 |
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