1309-A

Organization name

Pearl Technology AG

SRN

CH-MF-000018100

Manufacturer status

Active

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

• CW999

  RX only: Caution: Federal law restricts this device to sale by or on the order of a licensed health-care professional
• CW020

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

  Not sterile
• CW999

  Dispose of any product that is cracked or appears damaged

Primary placement in Germany; available across 31 countries total.

Trade name

not provided

UDI-DI code

07640178062016

Basic UDI-DI

764017806GantryCoverHT

Reference / catalog number

1309-A

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Reusable hygienic device shield for CT devices during invasive and non-invasive procedures to protect the CT gantry from penetrating fluids. Covers the lower half of the CT gantry.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 900 MU50

• Z11030699COMPUTED TOMOGRAPHS (CT) - OTHER

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