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Fortress®

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 386595Model FG-06552-001A

by Contract Medical International GmbH

Identity

Trade Name
Fortress® EUDAMED
Biotronik Fortress Introducer Sheath System FDA UDI
Generic Name
Vascular catheter introduction set, nonimplantable FDA UDI
Device Name
Fortress Introducer Sheath EUDAMED
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) dilators. FDA UDI
Model / Reference
FG-06552-001A EUDAMED
386595 EUDAMED
100 cm, 6F Straight FDA UDI
Description
Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) dilators. FDA UDI

Identifiers

Catalog Number
386595 FDA UDI
Primary DI / UDI-DI
04251244500085 EUDAMEDFDA UDI
Basic UDI-DI
B-04251244500085 EUDAMED
510(k) Number
K153197 FDA UDI
FDA Product Code
DYB FDA UDI
EMDN Code
C0599 CARDIOVASCULAR INTRODUCER SHEATHS - OTHER EUDAMED
GMDN Term
Vascular catheter introduction set, nonimplantable FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
870.1340 FDA UDI
Market of Registration
Austria EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 2.28 Millimeter FDA UDI
Length — 100 Centimeter FDA UDI

Fortress® by Contract Medical International GmbH — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Contract Medical International GmbH
EUDAMED SRN
DE-MF-000007409

Sources (2)

  • EUDAMED a6b79244-3fe0-4ccd-9afa-3cc4522d0415 61 fields · synced May 30, 2026
  • FDA UDI 0114b67b-7cd0-44aa-9b9a-d631e5a45c32 38 fields · synced May 30, 2026