1231-A

Organization name

Pearl Technology AG

SRN

CH-MF-000018100

Manufacturer status

Active

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

• CW020

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

  Not sterile
• CW999

  Dispose of any product that is cracked or appears damaged.
• CW999

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

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

07640178061446

Basic UDI-DI

764017806GantryCoverHT

Reference / catalog number

1231-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 device from penetrating fluids. Covers the lower half of the CT gantry. May only be used by medical personnel. Non-sterile and not to be used in the sterile field.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• 2042 MU50
• 1150 MU50
• <5mm
• Thickness folded in packaging: — 20–30 MU50

• Z11030699COMPUTED TOMOGRAPHS (CT) - OTHER

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