Organization name

Exact Medical Manufacturing, Inc

SRN

CN-MF-000001406

Manufacturer status

Active

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

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

Primary placement in Netherlands; available across 32 countries total.

Trade name

Spunlance Surgical Gown, Standard

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.

06975085700791

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.

697508570SG04MV

Reference / catalog number

EU003170

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 I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Gown, Standard with 2 Towels, Extra XL, Spunlace

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.

• T020401STANDARD SURGICAL GOWNS

• Class I medical devices in EUDAMED

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