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Sign in to claim this brandBionix, LLC
United States·US-MF-000020408
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 1670, Indian Wood Circle, Maumee, United States
- Website
- www.bionix.com
- —
- —
- [email protected]
- Phone
- +1 419 214 6050
- PRRC Contact
- Joshua Ball
- EUDAMED SRN
- US-MF-000020408
- FDA FEI Number
- 1526854
- DUNS Number
- 117844489
Catalogue (209)
Page 1 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pelvis Belly Large Abdominal Insert | PPRT-5106 | FDA UDI | Class II | Active |
| Lighted Placement Tool | 2850 | FDA UDI | Class I | Active |
| Prone Breast System | PBRT-6025-03 | FDA UDI | Class II | Active |
| SecureVac™ Immobilization System | SVRT-7915 | FDA UDI | Class II | Active |
| Preemie Transport Blanket | 21125 | FDA UDI | Class I | Unknown |
| SafeStraw™ Drinking Aid for Thin Liquid | 202 | FDA UDI | Class I | Unknown |
| Prone Breast, Hardware Kit, Head Rest Push Button Assembly Replacement | PBRT-6302 | FDA UDI | Class II | Active |
| Sample, Lighted FlexLoop | 22205 | FDA UDI | Class I | Unknown |
| SecureVac™ Immobilization System | SVRT-7600 | FDA UDI | Class II | Active |
| SecureVac™ Immobilization System | SVRT-7820-A | FDA UDI | Class II | Active |
| SecureVac™ Immobilization System | SVRT-7625 | FDA UDI | Class II | Active |
| Opti-Tatt™ Field Borders | UTRT-4300 | FDA UDI | Class I | Active |
| SecureFoam | 25038 | FDA UDI | Class II | Active |
| IsoMark™ | UTRT-3101 | FDA UDI | Class I | Unknown |
| SecureFoam | 5038 | FDA UDI | Class II | Active |
| OtoClear SprayWash Adapter Wand | 27219 | FDA UDI | Class I | Active |
| Ear Wax Removal Kit | 702 | FDA UDI | Class I | Active |
| SecureFoam | 5036 | FDA UDI | Class II | Unknown |
| Lighted Articulating - Sample | 22511 | FDA UDI | Class I | Active |
| Bionix, LLC | UTRT-3105 | FDA UDI | Class I | Active |
| Sample, Lighted Suction Handle | 22625 | FDA UDI | Class I | Active |
| Bionix, LLC | UTRT-3100 | FDA UDI | Class I | Active |
| Lighted Ear Curette Demo Pack (monthly mailer) | 22201 | FDA UDI | Class I | Active |
| Igloo Wound Irrigator | 25000 | FDA UDI | Class I | Active |
| Microsuction Stater Pack | 2650 | FDA UDI | Class II | Active |
| Bionix Development Corporation | SP-20913 | FDA UDI | Class II | Active |
| SecureVac™ Immobilization System | SVRT-7133 | FDA UDI | Class II | Active |
| Swaddler for Phototherapy | 1100 | FDA UDI | Class II | Unknown |
| Sample, OtoClear® Ear Irrigation System (220V) | SP-27247 | FDA UDI | Class I | Active |
| Sample, Lighted Forceps for Foreign Body Removal | SP-22750 | FDA UDI | Class I | Active |
| SafeStraw | 1510 | FDA UDI | Class I | Active |
| SecureFoam | 5037 | FDA UDI | Class II | Active |
| AfterSwim | 530 | FDA UDI | Class I | Unknown |
| OtoClear Tip Sample | 27230 | FDA UDI | Class I | Active |
| Pelvis Belly Replacement Face Cushion Assembly | PPRT-5107 | FDA UDI | Class II | Active |
| IsoMark™ | UTRT-3102 | FDA UDI | Class I | Active |
| Pelvis Belly Replacement Arm Rest Cushion | PPRT-5103 | FDA UDI | Class II | Active |
| Bionix Development Corporation | SP-20921 | FDA UDI | Class II | Active |
| OtoClear SprayWash System, Single Use Sample | 27291 | FDA UDI | Class I | Unknown |
| Bionix Development Corporation | SP-21105 | FDA UDI | Class II | Unknown |
| ShotBlocker® | SB-8003 | FDA UDI | Class I | Unknown |
| Pelvis Belly Multi-Treatment Base | 00-0601 | FDA UDI | Class II | Active |
| SafeStraw™ NeoTarget Co-brand | 203 | FDA UDI | Class I | Unknown |
| Prone Breast, Hand Post Assembly, Replacement | PBRT-6300 | FDA UDI | Class II | Active |
| Preemie Hand Splint | 21150 | FDA UDI | Class I | Unknown |
| Bionix, LLC | SP-23100 | FDA UDI | Class I | Active |
| Pelvis Belly Replacement Stomach Cushion - Medium | PPRT-5104 | FDA UDI | Class II | Active |
| IsoMark™ Sample, Pink Ink | SP-23102 | FDA UDI | Class I | Active |
| SutureOut | 28500 | FDA UDI | Class I | Active |
| Prone Breast Bridge: Large | PBRT-6240 | FDA UDI | Class II | Active |
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