FDA UDI
In Commercial Distribution
🇺🇸 United States
BoneFoam
DI: 00810075281620
·
Model: 925.ZDK-DOC-BX12
·
BONE FOAM, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
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Basic Information
- Brand Name
- BoneFoam
- Primary DI
- 00810075281620
- Version / Model
- 925.ZDK-DOC-BX12
- Catalog Number
- 925.ZDK-DOC-BX12
- Company Name
- BONE FOAM, INC.
- Labeler DUNS
- 079636174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2025-08-15
- Public Version
- 1
- Public Version Date
- 2025-08-25
- Public Version Status
- New
- Public Device Record Key
- 44327ea5-f237-4357-b8f6-4d65da8ddc2e
Device Description
Zero Degree Knee | DOC | Box of 12
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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 |
|---|---|---|---|---|
| IQI | ORTHOSIS, LIMB BRACE | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41542 | Leg/knee cushion | A soft pillow or pad intended to be placed under or between the leg(s)/knee(s) of a patient during the treatment/prevention of musculoskeletal and/or circulatory disorders. It is primarily intended for support when the patient is lying down, and may be used for one or more of the following: to reduce pressure on or between the legs, to improve postural alignment (e.g., of the spine or legs), to improve blood circulation in the lower extremities, and/or to prevent pressure sores/ulcers. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810075281613 | GS1 | ||||
| Primary | 00810075281620 | GS1 |