FDA UDI
In Commercial Distribution
🇺🇸 United States
BIOPSYBELL
DI: 08033860019693
·
Model: DISKOM
·
BIOPSYBELL SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- BIOPSYBELL
- Primary DI
- 08033860019693
- Version / Model
- DISKOM
- Catalog Number
- DKR1716CDFL10
- Company Name
- BIOPSYBELL SRL
- Labeler DUNS
- 438746708
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-28
- Public Version
- 1
- Public Version Date
- 2023-04-05
- Public Version Status
- New
- Public Device Record Key
- 39d711dd-2d9c-4417-9c75-b8c24bd3dfa4
Device Description
DISC DECOMPRESSION 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HRX | Arthroscope | Orthopedic | 888.1100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36077 | Diskectomy system, percutaneous, automatic | An automated system intended for the percutaneous (through the skin) removal of the nucleus pulposus from the lumbar disc. This system is used to resect and aspirate the nucleus pulposus in one step, eliminating the need for repeated insertion of the nucleotome. It provides an alternative to surgical diskectomy and is typically carried out under local anaesthesia. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033860019693 | GS1 |
Customer Contacts
- Phone
- +39053527850
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180315 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 160 | Millimeter | |
| Needle Gauge | 17 | Gauge |