FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOPSYBELL
DI: 08033860002008
·
Model: UNLUX SYSTEM
·
BIOPSYBELL SRL
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BIOPSYBELL
- Primary DI
- 08033860002008
- Version / Model
- UNLUX SYSTEM
- Catalog Number
- ULSEC1115C
- Company Name
- BIOPSYBELL SRL
- Labeler DUNS
- 438746708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-12
- Public Version
- 3
- Public Version Date
- 2025-11-05
- Public Version Status
- Update
- Public Device Record Key
- 08bba3d2-48fa-46e9-bee0-135b89c3e849
Device Description
NEEDLE FOR BONE-MARROW BIOPSY
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNW | Instrument, Biopsy | Gastroenterology, Urology | 876.1075 | 2 |
| FCG | Biopsy Needle | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16833 | Bone marrow biopsy procedure kit | A packaged collection of sterile equipment that includes a disposable biopsy needle and other supplies used to perform a histologic specimen aspiration during a bone marrow biopsy. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033860002008 | GS1 |
Customer Contacts
- Phone
- +39053527850
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130616 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 150 | Millimeter | |
| Needle Gauge | 11 | Gauge |