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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 18G X 100 MM FDA UDI
Model / Reference
MC18100-C0 FDA UDI
Description
Automatic disposable biopsy system 18G X 100 MM FDA UDI

Identifiers

Primary DI / UDI-DI
08056515885757 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

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Manufacturer

Manufacturer
Medax Unipersonale Srl

Sources (1)

  • FDA UDI 8ab33f90-c883-49de-8067-88c8de2c30d6 34 fields · synced May 30, 2026