Instruments for foot surgery

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref AR-301-B002Ref NS3801.005.M2

by Gebr. Brasseler GmbH & Co. KG

Identity

Trade Name: Shannon Corta, Round shank FDA UDI
KOMET Surgical Bur FDA UDI
Generic Name: Orthopaedic bur, single-use FDA UDI
Device Name: Instruments for foot surgery EUDAMED
Model / Reference: AR-301-B002 EUDAMEDFDA UDI
NS3801.005.M2 EUDAMED
NS3801.005..M2 FDA UDI

Identifiers

Catalog Number: AR-301-B002 FDA UDI
NS3801.005. FDA UDI
Primary DI / UDI-DI: 14053613290989 EUDAMEDFDA UDI
14053613279342 EUDAMEDFDA UDI
Basic UDI-DI: ++E2265328134P EUDAMED
FDA Product Code: GFF FDA UDI
EMDN Code: V0199 CUTTING DEVICES, SINGLE-USE - OTHER EUDAMED
GMDN Term: Orthopaedic bur, single-use FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 878.4820 FDA UDI
Market of Registration: 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

Yes

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: Cranial bur, single-use

Instruments for foot surgery by Gebr. Brasseler GmbH & Co. KG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cranial bur, single-use.

HiCUT Burs — adeor Medical AG · Class II
Disposable Sterile Vessel Punch — Zibo MK Medical Technology Co., Ltd. · Class IIa
PDS-2RDUL-15 — NAKANISHI INC. · Class IIa
GT PODO 7 mm spitz/pointed Schaft 2, 35 X 40 — LUKAS-ERZETT GmbH & Co.KG · Class I
Bone cutters — WILSON (Shanghai) Medical Device Co., Ltd. · Class IIa
J-Notch Burs — Stryker Instruments · Class IIa
Bone cutters — WILSON (Shanghai) Medical Device Co., Ltd. · Class IIa
GT PODO 5 mm rund/round Schaft 2, 35 x 35 — LUKAS-ERZETT GmbH & Co.KG · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	++E2265328134P	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Gebr. Brasseler GmbH & Co. KG
EUDAMED SRN: DE-MF-000006446

Sources (4)

EUDAMED 410c8ab2-be9f-4d97-8556-5401e0251b0b 61 fields · synced Sep 17, 2026
FDA UDI f09e9117-214d-45f1-a827-e9b46f7826f8 33 fields · synced May 30, 2026
FDA UDI a11b6418-6ea5-46fd-9d17-bc2b843af035 33 fields · synced May 30, 2026
EUDAMED 6b781468-dc39-4bc5-ba62-54ca7ddd3a18 61 fields · synced Sep 17, 2026