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MECRON Knee Straight L:500mm, OS:490mm, US:280mm

FDA UDI

Class I (US FDA UDI)

by Darco (Europe) GmbH

Identity

Trade Name
MECRON Knee Straight L:500mm, OS:490mm, US:280mm FDA UDI
Generic Name
Knee immobilizer FDA UDI
Device Name
M Black 0° / 50 cm FDA UDI
Model / Reference
OS500204 FDA UDI
Description
M Black 0° / 50 cm FDA UDI

Identifiers

Catalog Number
OS500204 FDA UDI
Primary DI / UDI-DI
00609271951112 FDA UDI
FDA Product Code
ITQ FDA UDI
GMDN Term
Knee immobilizer FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
890.3475 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Knee immobilizer

MECRON Knee Straight L:500mm, OS:490mm, US:280mm by Darco (Europe) GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Knee immobilizer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Darco (Europe) GmbH

Sources (1)

  • FDA UDI 39c8ac3e-5ad8-4994-bdf4-a2d519222832 34 fields · synced May 30, 2026