NEWDEAL

Address:Immeuble S�quoia 2, 97 all�e Alexandre Borodine,Saint Priest Rhone,FR

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

PIN, FIXATION, SMOOTH (HTY) (1)

Premarket Exempt

No Yes

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K-FIX® - 10381780357490 Catalog Number :

Device Description : The pack contains five radel K-FIX® ergonomically profiled pin protectors that h The pack contains five radel K-FIX® ergonomically profiled pin protectors that has three main functions in foot surgery for protruding wires.It protects patients and/or hospital staff from wire sharp ends.It prevents any inward pin migration as well as reducing bandage size.It allows easy removal of the wire by the surgeon.Its fixation requires no instrument. The protector ball is introduced until firm locking on the wire extremity previously bent.

Device Class : 2

Duns Number: 536935331

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 5

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