Identity
- Trade Name
- DISKOM EUDAMEDBIOPSYBELL FDA UDI
- Generic Name
- Diskectomy system, percutaneous, automatic FDA UDI
- Device Name
- DISCECTOMY SYSTEMS EUDAMEDDISC DECOMPRESSION NEEDLE FDA UDI
- Model / Reference
- DKR1716BCD EUDAMEDDISKOM FDA UDI
- Description
- DISC DECOMPRESSION NEEDLE FDA UDI
Identifiers
- Catalog Number
- DKR1716BCD FDA UDI
- Primary DI / UDI-DI
- 08033860026004 EUDAMEDFDA UDI
- Basic UDI-DI
- 8033860DISCFT01D77 EUDAMED
- 510(k) Number
- K180315 FDA UDI
- FDA Product Code
- HRX FDA UDI
- EMDN Code
- A01020102 ASPIRATION FINE NEEDLES AND KITS EUDAMED
- GMDN Term
- Diskectomy system, percutaneous, automatic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 160 Millimeter FDA UDINeedle Gauge — 17 Gauge FDA UDI
Category: Diskectomy system, percutaneous, automatic
Diskom by Biopsybell Srl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Diskectomy system, percutaneous, automatic.
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- CytoCut — M.D.L. S.R.L. · Class IIa
- Fine Needle Aspiration Biopsy Needle — Canyon Medical Inc. · Class IIa
- Fine Needle Aspiration Biopsy Needle — Canyon Medical Inc. · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8033860DISCFT01D77 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Biopsybell Srl
- EUDAMED SRN
- IT-MF-000011601
Sources (2)
- EUDAMED 12ccb253-ee65-4eb0-8a6e-88cdcabf64e3 61 fields · synced Jun 18, 2026
- FDA UDI fab964da-a37a-4ecc-aef0-5cf0b85c518c 37 fields · synced May 30, 2026