Organization name

PAUL HARTMANN AG

SRN

DE-PR-000019925

Manufacturer status

Active

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

• Do not resterilize
• Do not use if package is damaged
• Do not re-use
• Caution

Trade name

Set de Suture - 12

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.

04099467003309

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.

40495003310K7

Reference / catalog number

4701762

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

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

Status

On the market

Quantity

1

Additional product description

The suture/thread removal sets are single-use sets made with various components, intended to perform a suture or to remove the threads or the staples of a suture out of OR room. Risk class: II a

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

1 packaging level registered — each level carries its own UDI-DI.

• 04099467003309× 1 unitBase unit
  • 04099467003286× 90 units

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• H9099SUTURE DEVICES - OTHER

• Class III medical devices in EUDAMED

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