Organization name

Tricol Biomedical Inc

SRN

US-MF-000002003

Manufacturer status

Active

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

• Consult instructions for use
• Do not re-use
• Do not resterilize
• Do not use if package is damaged
• Do not use past indicated date
• Caution

  For external use only; Do not implant

• Do not use near the spine

  OTHER

• Do not apply over eyes

  OTHER

• Use promptly after opening

  OTHER

• Contains chitosan from shellfish

  OTHER

• Not made with natural rubber latex

  OTHER

• Seek Medical attention If bleeding does not stop or redness or swelling occurs. If you suspect an allergic reaction

  OTHER

Primary placement in Austria; available across 32 countries total.

Trade name

GuardaCare PRO 2"x2", 8ply

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00870053001350

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-00870053001350

Reference / catalog number

1012

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

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.

• M040501POLYSACCHARIDE HAEMOSTATIC DRESSINGS
• M0202010101NON-WOVEN FOLDED GAUZES, WITHOUT X-RAY DETECTABLE THREAD, STERILE

• Class III medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.