CYTOLOGY BRUSH

Organization name

Deltalab, S.L.

SRN

ES-MF-000000153

Manufacturer status

Active

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

• CW010

  1. It should not be used in case of pregnancy. 2. Reuse of this product may cause infections. 3. The use of the cytology brush does not present any difficulty for its intended uses. 4. Not suitable for any application other than its intended use. 5. Should not be used if dirt is observed on the brush. Discard the product if any are found to be broken or headless. 6. Strong pressure should not be exerted during use, as the cytology brush may break (unlikely as the force required to break it is considerable). In case of breakage, discard immediately. 7. Due to the intended use of the product, the recipients belong to the healthcare sector, and have biological waste containers, where the used product must be disposed of, and managed as biological waste. Cytology brushes, once used, must be decontaminated or treated as contaminated hospital waste. It is the responsibility of each laboratory to handle, treat and dispose of waste according to regulations. Unused brushes can be considered non-hazardous products and can be disposed of according to this criteria.

Primary placement in Spain; available across 12 countries total.

Trade name

CYTOLOGY BRUSH

UDI-DI code

08435263817409

Basic UDI-DI

84356058UDI-DI-1265

Reference / catalog number

440150

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

50

Additional product description

—

Additional information URL

https://www.deltalabgroup.com/eifus

Clinical sizes

No clinical sizes registered for this device.

• U089002DEVICES FOR GYNAECOLOGICAL CYTOLOGY

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