Identity
- Trade Name
- Nucleotome FDA UDI
- Generic Name
- Diskectomy system, percutaneous, automatic FDA UDI
- Device Name
- 2.0 MM Kit with aspiration bottle FDA UDI
- Model / Reference
- 22500 FDA UDI
- Description
- 2.0 MM Kit with aspiration bottle FDA UDI
Identifiers
- Catalog Number
- 22500 FDA UDI
- Primary DI / UDI-DI
- B067225001 FDA UDI
- 510(k) Number
- K844131 FDA UDI
- FDA Product Code
- HSZ FDA UDI
- GMDN Term
- Diskectomy system, percutaneous, automatic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.0 Millimeter FDA UDI
Category: Diskectomy system, percutaneous, automatic
Nucleotome by Clarus Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Diskectomy system, percutaneous, automatic.
- Biopsy Needle — Argon Medical Devices, Inc. · Class IIa
- INTRODUTTORE — BIOPSYBELL SRL · Class IIa
- CHIBELL CON SIRINGA — BIOPSYBELL SRL · Class IIa
- CHIBELL — BIOPSYBELL SRL · Class IIa
- Biopsy Needle — Argon Medical Devices, Inc. · Class IIa
- 0ME2320 — Biomedical S.r.l. · Class IIa
- 0ME1810 — Biomedical S.r.l. · Class IIa
- DISKIT — BIOPSYBELL SRL · Class IIa
Cleared under the same submission
K844131 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Clarus Medical, Llc
Sources (1)
- FDA UDI 5ae9555d-6b9c-4f86-a7cd-56b5163ea2b4 37 fields · synced May 30, 2026