Organization name

New World Medical, Inc.

SRN

US-MF-000007440

Manufacturer status

Active

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

• CW010

  Read the instructions before use
• CW009

  Do not reuse
• CW001

  Do not re-sterilize
• CW007

  Do not use if the package is damaged, open, or if the seal appears damaged.
• CW032

  Do not use the device past the indicated expiration date.
• CW011

  Physician training is required before use of this instrument.

Primary placement in Netherlands; available across 22 countries total.

Trade name

KDB GLIDE

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.

00892064002003

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-00892064002003

Reference / catalog number

10-0065

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 IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Ophthalmic Surgical Instrument

Additional information URL

https://www.newworldmedical.com/professional-resources/instructions-for-use

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.

• Q021199OPHTHALMIC SURGERY INSTRUMENTS, SINGLE-USE - OTHER

• Class IIa medical devices in EUDAMED

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