Biopsybell

FDA UDI

Class II (US FDA UDI)

by Biopsybell Srl

Identity

Trade Name: BIOPSYBELL FDA UDI
Generic Name: Bone marrow biopsy procedure kit FDA UDI
Device Name: Bone marrow biopsy or explantation needle with anti-luxation system FDA UDI
Model / Reference: UNLUX SYSTEM FDA UDI
Description: Bone marrow biopsy or explantation needle with anti-luxation system FDA UDI

Identifiers

Catalog Number: ULSEC0915C FDA UDI
Primary DI / UDI-DI: 08033860043438 FDA UDI
510(k) Number: K130616 FDA UDI
FDA Product Code: KNW FDA UDI
FCG FDA UDI
GMDN Term: Bone marrow biopsy procedure kit 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 9 Gauge FDA UDI
Length — 150 Millimeter FDA UDI

Category: Bone marrow biopsy procedure kit

Biopsybell by Biopsybell Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K130616 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 II	Pending data

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Manufacturer

Manufacturer: Biopsybell Srl

Sources (1)

FDA UDI 5a546cf5-080e-43c3-9c8f-0a2f799f9964 37 fields · synced May 31, 2026