Bone Resector, Ball Tip

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref JSBBR274543Ref JSBDR3613

by Joimax GmbH

Identity

Trade Name: Bone Resector, Ball Tip EUDAMED
Deflector Bone Resector, Ball-Tip, disposable EUDAMED
bone resector FDA UDI
deflector FDA UDI
Generic Name: Arthroscopic shaver system blade, single-use FDA UDI
Device Name: Bone Resector, Ball Tip EUDAMEDFDA UDI
Deflector Bone Resector, Ball-Tip, disposable EUDAMEDFDA UDI
Deflector Diamond Abrasor, disposable EUDAMED
Barrel Cutter, Barrel Tip, with distal protection EUDAMED
Model / Reference: JSBBR274543 EUDAMEDFDA UDI
JSBDR3613 EUDAMEDFDA UDI
Description: Bone Resector, Ball Tip FDA UDI
Deflector Bone Resector, Ball-Tip, disposable FDA UDI

Identifiers

Catalog Number: JSBBR274543 FDA UDI
JSBDR3613 FDA UDI
Primary DI / UDI-DI: 04250337116356 EUDAMEDFDA UDI
04250337115632 EUDAMEDFDA UDI
Basic UDI-DI: B-04250337116356 EUDAMED
B-04250337115632 EUDAMED
42503371DEFLABR7K EUDAMED
42503371DEFLRESAK EUDAMED
Direct Marketing DI: 04250337115632 EUDAMED
04250337116356 EUDAMED
FDA Product Code: HWE FDA UDI
EMDN Code: Z12130585 MOTORISED ORTHOPAEDIC SURGERY SYSTEM INSTRUMENTS - CONSUMABLES EUDAMED
GMDN Term: Arthroscopic shaver system blade, single-use FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 878.4820 FDA UDI
Market of Registration: Austria EUDAMED
Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Spinal shaver system blade

Bone Resector, Ball Tip by Joimax GmbH — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal shaver system blade.

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Single-use Sterile Bur — Chongqing Xishan Science & Technology Co., Ltd. · Class IIa

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	B-04250337116356	Class IIa	Active
EUDAMED	European Union	CE/MDD	B-04250337116356	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Joimax GmbH
EUDAMED SRN: DE-MF-000009201

Sources (6)

EUDAMED e7dc14f0-7ba1-4700-af9e-24be41d2484c 61 fields · synced Jul 26, 2026
EUDAMED 4d5faf22-6480-4c51-9b1c-c540654c2179 61 fields · synced May 18, 2026
FDA UDI b11bc6ac-652f-4c78-95b2-857b3f3115ce 36 fields · synced May 30, 2026
FDA UDI d4a20eea-c660-4e3b-94fb-e25538401386 36 fields · synced May 30, 2026
EUDAMED 575c5964-36e5-49f7-be18-0742a279618a 61 fields · synced Jun 19, 2026
EUDAMED b834781b-1efd-40c9-be7e-0a0b76ad6a66 61 fields · synced Jul 20, 2026