FDA UDI
In Commercial Distribution
🇺🇸 United States
BoneFoam
DI: 00810075280883
·
Model: 104.SLPS-SUK-BX5
·
BONE FOAM, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
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Basic Information
- Brand Name
- BoneFoam
- Primary DI
- 00810075280883
- Version / Model
- 104.SLPS-SUK-BX5
- Catalog Number
- 104.SLPS-SUK-BX5
- Company Name
- BONE FOAM, INC.
- Labeler DUNS
- 079636174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2022-05-22
- Public Version
- 5
- Public Version Date
- 2025-08-18
- Public Version Status
- Update
- Public Device Record Key
- 7d2d972e-06b8-4aa3-ace8-fdb3c6eae480
Device Description
Sideline | Single Use Kit | Box of 5
Device Characteristics
- Single Use
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65178 | Operating table patient positioning set, single-use | A collection of devices intended to support and stabilize in a desired position a patient, or their body parts, on an operating table during a medical procedure (e.g., bariatric surgery, orthopaedic surgery, endotracheal tube intubation); some types may be intended to prevent patient sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: padded positioners dedicated to a body part such as arm, leg, shoulder, neck, or feet positioner, a headrest, a non-slip pad/bolster placed underneath the patient (e.g., cervical notch), and securing devices (e.g., straps). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810075281200 | GS1 | ||||
| Primary | 00810075280883 | GS1 |