FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOPSYBELL
DI: 08033860044732
·
Model: BONE ACCESS NEEDLE
·
BIOPSYBELL SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- BIOPSYBELL
- Primary DI
- 08033860044732
- Version / Model
- BONE ACCESS NEEDLE
- Catalog Number
- BAN0815HCDTW
- Company Name
- BIOPSYBELL SRL
- Labeler DUNS
- 438746708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-12
- Public Version
- 1
- Public Version Date
- 2024-04-22
- Public Version Status
- New
- Public Device Record Key
- 1b2e7415-7233-4e1b-b213-20d2f275eb65
Device Description
BONE ACCESS NEEDLE
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58031 | Bone access channel kit | A collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08033860044749 | GS1 | BOX | 5 | In Commercial Distribution | |
| Primary | 08033860044732 | GS1 |
Customer Contacts
- Phone
- +39053527850
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 08 | Gauge | |
| Length | 150 | Millimeter |