Identity
- Trade Name
- SecureFoam FDA UDI
- Generic Name
- Radiological whole-body positioner FDA UDI
- Device Name
- SecureFoam - Medium FDA UDI
- Model / Reference
- 5037 FDA UDI
- Description
- SecureFoam - Medium FDA UDI
Identifiers
- Catalog Number
- 5037 FDA UDI
- Primary DI / UDI-DI
- 00714646001207 FDA UDI
- 510(k) Number
- K040773 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiological whole-body positioner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Radiological whole-body positioner
SecureFoam by Bionix, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K040773 also covers:
- Pelvis Belly Large Abdominal Insert — Bionix, LLC
- Pelvis Belly Multi-Treatment Base — Bionix, LLC
- Pelvis Belly Plus System — Bionix, LLC
- Pelvis Belly Replacement Arm Rest Cushion — Bionix, LLC
- Pelvis Belly Replacement Face Cushion Assembly — Bionix, LLC
- Pelvis Belly Replacement Leg Cushion — Bionix, LLC
- Pelvis Belly Replacement Stomach Cushion - Medium — Bionix, LLC
- Pelvis Belly Replacement Stomach Cushion - Small — Bionix, LLC
- Prone Breast Bridge: Large — Bionix, LLC
- Prone Breast System — Bionix, LLC
- Prone Breast, Arm Rest, Replacement — Bionix, LLC
- Prone Breast, Breast Bridge, Small Opening, Replacement — Bionix, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bionix, LLC
Sources (1)
- FDA UDI 3de0a86c-e7ee-45e1-93fe-0ed252c8b841 37 fields · synced May 30, 2026