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Selectra Slitter

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 383119Model Selectra Slitter Tool

by BIOTRONIK SE & Co. KG

Identity

Trade Name
Selectra Slitter EUDAMEDFDA UDI
Generic Name
Intravascular catheter slitter FDA UDI
Model / Reference
Selectra Slitter Tool EUDAMED
383119 EUDAMEDFDA UDI

Identifiers

Catalog Number
383119 FDA UDI
Primary DI / UDI-DI
04035479124564 EUDAMEDFDA UDI
Basic UDI-DI
4035479BUDI00064QC EUDAMED
FDA Product Code
DQY FDA UDI
EMDN Code
C058099 CARDIOCIRCULATORY SYSTEM INTRODUCERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
GMDN Term
Intravascular catheter slitter FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
870.1250 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

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Selectra Slitter by BIOTRONIK SE & Co. KG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BIOTRONIK SE & Co. KG
EUDAMED SRN
DE-MF-000005049

Sources (2)

  • EUDAMED 25109966-0487-4a57-9bb0-d4b0b91d2791 61 fields · synced Jul 17, 2026
  • FDA UDI 0ee64014-9d80-4664-a5b2-402b713d8858 35 fields · synced May 30, 2026