Identity
- Trade Name
- CytoCut FDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- DISPOSABLE CHIBA NEEDLE 21G X 200 mm FOR ASPIRATED CYTO-HISTOLOGICAL BIOPSY FDA UDI
- Model / Reference
- PB2120 FDA UDI
- Description
- DISPOSABLE CHIBA NEEDLE 21G X 200 mm FOR ASPIRATED CYTO-HISTOLOGICAL BIOPSY FDA UDI
Identifiers
- Catalog Number
- PB2120 FDA UDI
- Primary DI / UDI-DI
- 08056138584839 FDA UDI
- FDA Product Code
- GAA FDA UDI
- GMDN Term
- Body aspiration needle, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 21 Gauge FDA UDILength — 200 Millimeter FDA UDI
Category: Body aspiration needle, single-use
CytoCut by M.d.l. S.r.l. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Body aspiration needle, single-use.
- Arthrex® — Arthrex, Inc. · Class I
- ECOJEKT — H.S. HOSPITAL SERVICE SPA · Class I
- Chiba Needle Marked — REMINGTON MEDICAL, INC. · Class I
- Echotip — COOK INCORPORATED · Class I
- COMPLETE-CHIBA MR — STERYLAB SRL · Class II
- Invivo — Philips DS North America LLC · Class II
- BIOMOL — H.S. HOSPITAL SERVICE SPA · Class II
- MReye — COOK INCORPORATED · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- M.d.l. S.r.l.
Sources (2)
- FDA UDI 76caaf01-018d-4d57-9f38-63c5728b3b5e 35 fields · synced Oct 7, 2026
- EUDAMED 1 fields · synced Jun 1, 2026