Organization name

CIVCO Medical Instruments Co., Inc. dba CIVCO and CIVCO Medical Solutions

SRN

US-MF-000008229

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 32 countries total.

Trade name

Surgi-Boot Transducer Cover

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

10841436110379

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

0841436101TD201A12RM

Reference / catalog number

UA0075

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Sterile (15.2 x 244cm) polyethylene telescopically-folded cover with attached form-fitting NeoGuard™ tip for use with BK Medical 8809 transducers

Additional information URL

https://www.civco.com/

Clinical sizes

• 244 MU10
• 15.2 MU28

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• T030102COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.