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Stratos

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref 012-03450

by MedXpert GmbH

Identity

Trade Name
STRATOS EUDAMED
Titanium rib clip, left, 45°, XL FDA UDI
Generic Name
Rib/rib cage internal fixation/bracing system fixation grip/anchor FDA UDI
Device Name
012-03450 Titan Rippenklammer, links, 45°, XL EUDAMED
Model / Reference
012-03450 EUDAMEDFDA UDI

Identifiers

Catalog Number
012-03450 FDA UDI
Primary DI / UDI-DI
04260029580839 EUDAMEDFDA UDI
Basic UDI-DI
B-04260029580839 EUDAMED
FDA Product Code
HRS FDA UDI
EMDN Code
P09120299 OSTEOSYNTHESIS NAILS - OTHER EUDAMED
GMDN Term
Rib/rib cage internal fixation/bracing system fixation grip/anchor FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

Yes

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

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Stratos by MedXpert GmbH — Class IIb — 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
MedXpert GmbH
EUDAMED SRN
DE-MF-000005489

Sources (2)

  • EUDAMED 0956badc-b1d7-4e1b-82df-c87c94908e11 61 fields · synced May 31, 2026
  • FDA UDI cee395f9-500b-47e0-a446-5d5f6e155a34 34 fields · synced May 29, 2026