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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 3 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SecureVac™ Immobilization System | SVRT-7130 | FDA UDI | Class II | Active |
| ShotBlocker® | 08002 | FDA UDI | Class I | Active |
| Prone Breast, Breast Bridge, Small Opening, Replacement | PBRT-6242 | FDA UDI | Class II | Active |
| SecureVac™ Immobilization System | SVRT-7535-A | FDA UDI | Class II | Active |
| PouchPro | 25040 | FDA UDI | Class II | Unknown |
| SafeStraw | 1500 | FDA UDI | Class I | Active |
| Igloo Wound Irrigator | 5250 | FDA UDI | Class I | Active |
| Sample, Lighted Placement Tool | SP-22850 | FDA UDI | Class I | Active |
| AlphaCleanse | 25750 | FDA UDI | Class II | Unknown |
| Pelvis Belly Replacement Stomach Cushion - Small | PPRT-5108 | FDA UDI | Class II | Active |
| Tabletop Waterpik Adapter Wands | 27210 | FDA UDI | Class I | Unknown |
| OtoClear® Irrigation Tips | 7200ST | FDA UDI | Class I | Active |
| AlphaCleanse® Antimicrobial Wound Care System | WI-5750 | FDA UDI | Class II | Unknown |
| SecureVac™ Immobilization System | SVRT-7635 | FDA UDI | Class II | Active |
| SecureFoam | 5037 | FDA UDI | Class II | Unknown |
| Bionix Development Corporation | GF-09510 | FDA UDI | Class II | Unknown |
| SutureOut | 8500 | FDA UDI | Class I | Active |
| TruGuard™ | HNRT-3501 | FDA UDI | Class II | Active |
| SecureFoam | 25036 | FDA UDI | Class II | Active |
| OtoClear Portable Ear Irrigation System (110 v) | 27245 | FDA UDI | Class I | Active |
| OtoClear® Tabletop WaterPik® Kit | 7240 | FDA UDI | Class I | Unknown |
| OtoClear® Ear Irrigation System (220V) | OC-07282 | FDA UDI | Class I | Active |
| Pelvis Belly Replacement Leg Cushion | PPRT-5101 | FDA UDI | Class II | Active |
| Bionix Development Corporation | SP-21100 | FDA UDI | Class II | Unknown |
| SecureFoam | 5036 | FDA UDI | Class II | Unknown |
| OtoClear AquaBot Adapter Wand | 27217 | FDA UDI | Class I | Active |
| Bionix Development Corporation | SP-20922 | FDA UDI | Class II | Active |
| SecureFoam | 5038 | FDA UDI | Class II | Unknown |
| Opti-Tatt™ Crosshairs | UTRT-4200 | FDA UDI | Class I | Active |
| Lighted Suction | 2625 | FDA UDI | Class I | Active |
| OtoClear® Ear Irrigation System (220V) | OC-07247 | FDA UDI | Class I | Active |
| SafeStraw™ NeoTarget Co-brand | 214 | FDA UDI | Class I | Unknown |
| SecureVac™ Immobilization System | SVRT-7132 | FDA UDI | Class II | Active |
| SprayWash Adapter Wand | 27221 | FDA UDI | Class I | Active |
| ClearLook Lighted AngleLoop, Refill | 3410 | FDA UDI | Class I | Active |
| Ear Wax Removal Kit 12 Ct. Case | 704 | FDA UDI | Class I | Active |
| Preemie Transport Blanket | 21126 | FDA UDI | Class I | Unknown |
| ShotBlocker | SB-08004 | FDA UDI | Class I | Active |
| Prone Breast, Arm Rest, Replacement | PBRT-6255 | FDA UDI | Class II | Active |
| Prone Breast, Leg Cushion, Replacement | PBRT-6270 | FDA UDI | Class II | Active |
| Swaddler for Phototherapy | 1105 | FDA UDI | Class II | Unknown |
| ClearLook Lighted FlexLoop, Refill | 3440 | FDA UDI | Class I | Active |
| SafeStraw™ Variety Pack | 1520 | FDA UDI | Class I | Active |
| SecureVac™ Immobilization System | SVRT-7380 | FDA UDI | Class II | Active |
| SecureFoam | 5038 | FDA UDI | Class II | Unknown |
| OtoClear Ear Irrigation System | 7245 | FDA UDI | Class I | Active |
| Prone Breast, Cushion, Contralateral Breast Insert, 15 degree, Replacement | PBRT-6243 | FDA UDI | Class II | Active |
| Preemie Transport Blanket | 1126 | FDA UDI | Class I | Unknown |
| SecureVac Wing Board Cushion | SVRT-7138 | FDA UDI | Class II | Active |
| T-Form SecureVac Box Adaptor | SVRT-6017 | FDA UDI | Class II | Active |
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