FDA UDI
In Commercial Distribution
🇺🇸 United States
BoneFoam
DI: 00810075280838
·
Model: 104.SLPS
·
BONE FOAM, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BoneFoam
- Primary DI
- 00810075280838
- Version / Model
- 104.SLPS
- Catalog Number
- 104.SLPS
- Company Name
- BONE FOAM, INC.
- Labeler DUNS
- 079636174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-22
- Public Version
- 3
- Public Version Date
- 2023-04-11
- Public Version Status
- Update
- Public Device Record Key
- e2060541-8c0e-440d-8440-c79dd16d6ec2
Device Description
Lateral Lumbar Positioning System (includes Lateral Lumbar Positioning System Torso Base, Lateral Lumbar Positioning System Lower Base, Lateral Lumbar Positioning System Axillary Bolster, Lateral Lumbar Positioning System Hip Bolster, the Shark Small with Straps, and one Lateral Lumbar Positioning System Single Use Kit)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KQZ | COMPONENT, TRACTION, NON-INVASIVE | Orthopedic | 888.5890 | 1 |
| CCX | SUPPORT, PATIENT POSITION | Anesthesiology | 868.6820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58878 | Freestanding patient positioner, reusable | A preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810075280838 | GS1 |