RTD Wound Dressing

Organization name

Keneric Healthcare, LLC

SRN

US-MF-000013577

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW264

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW001

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.
• CW135

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

  Contraindications: RTD Wound Dressings are not indicated for burns, pregnant or breastfeeding women, or children. Precautions: In the event of clinical infection, the RTD Wound Dressing is not intended to replace systemic therapy or the appropriate course of treatment for infections. When choosing a wound dressing, clinicians should consider any potential adverse effects for any patient. Stop using straight away if an allergic reaction is suspected. Caution: POM. Keep out of the reach of children. This device may only be sold by or on the order of a registered physician or wound care professional. For use at home: The RTD Wound Dressing should only be used by or under the direct supervision of a wound care professional.

Primary placement in Malta; available across 12 countries total.

Trade name

RTD Wound Dressing

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.

10856227004188

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-10856227004188

Reference / catalog number

RTD75081614

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 IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

RTD Wound Dressing 8" x 16" (20cm x 40cm) box of five

Additional information URL

https://www.kenerichealthcare.com/

Clinical sizes

• 40 MU10
• 0.6 MU10
• 20 MU10

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

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

• M04040602POLYURETHANE DRESSINGS, COMBINED WITH OTHER SUBSTANCES

• Class IIb medical devices in EUDAMED

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