Bmn J Type

FDA UDI

Class II (US FDA UDI)

by H.s. Hospital Service Spa

Identity

Trade Name: BMN J TYPE FDA UDI
Generic Name: Bone marrow biopsy needle, single-use FDA UDI
Device Name: BMN J TYPE 11GX150MM FDA UDI
Model / Reference: BMN J TYPE FDA UDI
Description: BMN J TYPE 11GX150MM FDA UDI

Identifiers

Catalog Number: J1115 FDA UDI
Primary DI / UDI-DI: 08033003344590 FDA UDI
510(k) Number: K013070 FDA UDI
FDA Product Code: KNW FDA UDI
GMDN Term: Bone marrow biopsy needle, single-use 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: Length — 150 Millimeter FDA UDI
Needle Gauge — 11 Gauge FDA UDI

Category: Bone marrow biopsy needle, single-use

Bmn J Type by H.s. Hospital Service Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone marrow biopsy needle, single-use.

Bone Marrow Tray — Argon Medical Devices, Inc. · Class II
Bone Marrow Tray — Argon Medical Devices, Inc. · Class I
MEDBONE — Medax Unipersonale Srl · Class II
Bone Marrow Biopsy — Argon Medical Devices, Inc. · Class I
Monoject — Cardinalhealth · Class II
MEDLOCK — Medax Unipersonale Srl · Class II
Bone Marrow Biopsy Needle, RBN-116 — RANFAC CORP. · Class II
Faset — Dio Medical Co., Ltd. · U

Cleared under the same submission

K013070 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: H.s. Hospital Service Spa

Sources (1)

FDA UDI f7c48f95-2cb0-48bd-99c9-c3023768f631 37 fields · synced May 31, 2026