BTX101008100

Organization name

Bandtex Grup S.R.L.

SRN

RO-MF-000004081

Manufacturer status

Active

Primary placement in Romania; available across 1 country total.

Trade name

not provided

UDI-DI code

05944792000020

Basic UDI-DI

5944792NSTERGAUZESWABS1MR

Reference / catalog number

BTX101008100

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

Non-sterile gauze compresses, both cut and folded, are medical devices intended for both non-invasive procedures and for individual personal hygiene and can be used both within hospital units, clinics and medical offices, but also by individual users. These medical devices are disposable and can be used for: cleaning the skin, as a secondary dressing for wounds, applied over the sterile primary dressing that provides the protective barrier of the wound, with the role of absorbing blood or other type of excess exudate or protecting against abrasion or mechanical shock. Being non-sterile medical devices, they are not used in direct contact with an open wound. They can be used as a primary dressing or in cleaning and debriding open wounds only after their sterilization by a standardized and validated method.

Additional information URL

https://www.sanrotex.ro/

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.

• M0201020102COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE