Organization name

Summit Medical, LLC

SRN

US-MF-000026771

Manufacturer status

Active

9 warnings recorded — scroll inside the panel to see all entries.

• CW011

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW999

  This device is not designed, sold or intended for use except as indicated or prescribed by a physician. Some conditions for which ventilation tubes may not be the therapy of choice include: • Cases of otitis media which respond favorably to drug therapy alone.
• CW999

  Avoid fluid contact with ear.
• CW999

  The surgeon is encouraged to carefully choose a tube size, style and material to meet the needs of each specific clinical situation, while minimizing adverse effects.

Primary placement in Germany; available across 19 countries total.

Trade name

Baxter Bevel Button, SI, 1.27 mm

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.

00385640001427

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.

B-00385640001427

Reference / catalog number

VT-0606-01

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 IIb

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Baxter Bevel Button, Silicone, 1.27 mm Lumen

Additional information URL

https://summitmedicalusa.com/

Clinical sizes

• 1.27 MU50

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

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

• Q03040199EAR DRAINAGE AND VENTILATION DEVICES - OTHER

• Class IIb medical devices in EUDAMED

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