FDA UDI
In Commercial Distribution
🇺🇸 United States
BoneFoam
DI: 00810075281408
·
Model: 925.HIPPY-DBC-BX20
·
BONE FOAM, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- BoneFoam
- Primary DI
- 00810075281408
- Version / Model
- 925.HIPPY-DBC-BX20
- Catalog Number
- 925.HIPPY-DBC-BX20
- Company Name
- BONE FOAM, INC.
- Labeler DUNS
- 079636174
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2024-05-22
- Public Version
- 5
- Public Version Date
- 2025-08-18
- Public Version Status
- Update
- Public Device Record Key
- 04b51792-137c-4b20-9e04-988487822bfe
Device Description
Hippy | Disposable Barrier Cover | Box of 20
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 |
|---|---|---|---|---|
| KME | Bedding, Disposable, Medical | General Hospital | 880.6060 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12535 | Medical equipment/instrument drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. 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 | 00810075281415 | GS1 | ||||
| Primary | 00810075281408 | GS1 |