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FastCutE

FDA UDI

Class I (US FDA UDI)

by M.d.l. S.r.l.

Identity

Trade Name
FastCutE FDA UDI
Generic Name
End-cut biopsy gun needle FDA UDI
Device Name
DISPOSABLE NEEDLE FOR SOFT TISSUE BIOPSY 14G X 100 mm, COMPATIBLE AUTOMATIC PROMAG 2.2 ® GUN FDA UDI
Model / Reference
VE1410 FDA UDI
Description
DISPOSABLE NEEDLE FOR SOFT TISSUE BIOPSY 14G X 100 mm, COMPATIBLE AUTOMATIC PROMAG 2.2 ® GUN FDA UDI

Identifiers

Catalog Number
VE1410 FDA UDI
Primary DI / UDI-DI
08056138586925 FDA UDI
FDA Product Code
MJG FDA UDI
GMDN Term
End-cut biopsy gun needle 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
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 100 Millimeter FDA UDI
Needle Gauge — 14 Gauge FDA UDI

Category: End-cut biopsy gun needle

FastCutE by M.d.l. S.r.l. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as End-cut biopsy gun needle.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
M.d.l. S.r.l.

Sources (1)

  • FDA UDI 6a3dbfbe-b3d4-4a64-8512-4ded61a56471 35 fields · synced Jun 8, 2026