Organization name

Integra LifeSciences Corporation

SRN

US-MF-000007196

Manufacturer status

Active

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

• Excision of the wound must be performed thoroughly to remove all eschar or nonviable tissue from the wound bed. Integra Template will not take to nonviable tissue. Leaving any remaining nonviable tissue may create an environment for bacterial growth.

  OTHER

• Hemostasis must be achieved prior to applying Integra Template. Inadequate control of bleeding will interfere with the incorporation of Integra Template.

  OTHER

• Integra Template should not be used on clinically diagnosed infected wounds.

  OTHER

• When using Integra Meshed Dermal Regeneration Template with Negative Pressure Wound Therapy, follow Contraindications for the specific Negative Pressure Wound Therapy device utilized, such as in the presence of: - Exposed arteries, veins, organs, anastomotic sites or nerves - Malignancy in the wound - Untreated osteomyelitis - Untreated malnutrition - Necrotic tissue (with or without eschar present) - Non-enteric and unexplored fistulas - Sensitivity to silver (if silver dressings are used)

  OTHER

• When using Integra Meshed Dermal Regeneration Template with Negative Pressure Wound Therapy, follow Warnings and Precautions for the specific Negative Pressure Wound Therapy device utilized.

  OTHER

Primary placement in Belgium; available across 19 countries total.

Trade name

Integra®

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.

10381780356233

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-10381780356233

Reference / catalog number

M88101

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

INTEGRA Meshed Dermal Regeneration Template - terminally sterilized (ts) - International

Additional information URL

https://labeling.integralife.com/

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.

• P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

• Class III medical devices in EUDAMED

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