← Back to catalogue

Medcut

FDA UDI

Class II (US FDA UDI)

by Medax Unipersonale Srl

Identity

Trade Name
MEDCUT FDA UDI
Generic Name
Soft-tissue biopsy procedure kit, non-medicated FDA UDI
Device Name
Automatic disposable biopsy system 14G X 160 MM FDA UDI
Model / Reference
MC14160-00 FDA UDI
Description
Automatic disposable biopsy system 14G X 160 MM FDA UDI

Identifiers

Primary DI / UDI-DI
08056515884514 FDA UDI
510(k) Number
K172344 FDA UDI
FDA Product Code
KNW FDA UDI
GMDN Term
Soft-tissue biopsy procedure kit, non-medicated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1075 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Soft-tissue biopsy procedure kit, non-medicated

Medcut by Medax Unipersonale Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Soft-tissue biopsy procedure kit, non-medicated.

Cleared under the same submission

K172344 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medax Unipersonale Srl

Sources (1)

  • FDA UDI 9c41ac1c-f120-43cc-aa71-1a8e63f7a1ec 34 fields · synced May 30, 2026