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 13GX60MM FDA UDI
Model / Reference: BMN J TYPE FDA UDI
Description: BMN J TYPE 13GX60MM FDA UDI

Identifiers

Catalog Number: J1306 FDA UDI
Primary DI / UDI-DI: 08033003349625 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: Needle Gauge — 13 Gauge FDA UDI
Length — 60 Millimeter 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

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

Manufacturer

Manufacturer: H.s. Hospital Service Spa

Sources (1)

FDA UDI 166fed7f-d7a6-428d-8f38-337585fda574 37 fields · synced Jun 8, 2026