IM-10

Organization name

INORIS MEDICAL SP. Z O.O.

SRN

PL-MF-000016864

Manufacturer status

Active

Primary placement in Poland; available across 1 country total.

Placed on the market in Poland; per-country availability dates not published.

Trade name

not provided

UDI-DI code

05902596226060

Basic UDI-DI

B-05902596226060

Reference / catalog number

IM-10

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Semi-open Clip-On Biteguard for adults is designed to protect both patient and the equipment during medical instrumentation. Due to its U shape it can be easily applied even when the instrument is in patient's mouth. Its optimal position is when the outside wings are placed between lips and teeth. It ensures that biteguard stays in correct position for the entire procedure. Clip-On Biteguard secures both patient and the instrument. It is designed to be used during gastroscopy, bronchoscopy and transesophageal echocardiography.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

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

• G030804GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS

Certificate health across this manufacturer's portfolio.