FDA UDI
In Commercial Distribution
🇺🇸 United States
SecureFoam
DI: 00714646001207
·
Model: 5037
·
Bionix, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- SecureFoam
- Primary DI
- 00714646001207
- Version / Model
- 5037
- Catalog Number
- 5037
- Company Name
- Bionix, LLC
- Labeler DUNS
- 117844489
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-05-31
- Public Version
- 1
- Public Version Date
- 2024-06-10
- Public Version Status
- New
- Public Device Record Key
- 3de0a86c-e7ee-45e1-93fe-0ed252c8b841
Device Description
SecureFoam - Medium
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYE | Accelerator, linear, medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40902 | Radiological whole-body positioner | A device comprised of fixed or adjustable position elements designed to ensure adequate positioning and/or immobilization of a patient's whole body during diagnostic imaging, image guided surgical or interventional procedures, and/or radiation therapy procedures; it may in addition be used to position a patient’s body part (however it is not dedicated to a specific part of the body). It is in the form of a frame, board, cushion, or preformed pad and may be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 10714646001204 | GS1 | ||||
| Primary | 00714646001207 | GS1 |
Customer Contacts
- Phone
- +1(800)551-7096
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K040773 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 65 – 95 Degrees Fahrenheit