MONDEAL Medical Systems GmbH

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Filters

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

Plate, Fixation, Bone (HRS) (3) WASHER, BOLT NUT (HTN) (3) REAMER (HTO) (2) Screw, fixation, bone (HWC) (2)

Premarket Exempt

Yes No

Clear

MONDEAL - 04050435040429 Catalog Number : 27-03505

Device Description : 12-hole Calcaneus Plate large right M3 green

Device Class : 2

Duns Number: 312546955

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040436 Catalog Number : 27-03506

Device Description : 12-hole Calcaneus Plate large left M3 green

Device Class : 2

Duns Number: 312546955

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040511 Catalog Number : 27-03749

Device Description : 4-hole Compression Fibula-Plate M3 green

Device Class : 2

Duns Number: 312546955

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040528 Catalog Number : 27-03773

Device Description : 6-hole Compression Fibula-Plate M3 green

Device Class : 2

Duns Number: 312546955

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040535 Catalog Number : 27-03798

Device Description : 8-hole Compression Fibula-Plate M3 green

Device Class : 2

Duns Number: 312546955

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040542 Catalog Number : 27-03902

Device Description : Washer Module 2 gold

Device Class : 2

Duns Number: 312546955

Premarket Exempt : No

Product Code : HTN

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040559 Catalog Number : 27-03903

Device Description : Washer Module 3 green

Device Class : 2

Duns Number: 312546955

Premarket Exempt : No

Product Code : HTN

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040566 Catalog Number : 27-03904

Device Description : Washer Module 4 grey

Device Class : 2

Duns Number: 312546955

Premarket Exempt : No

Product Code : HTN

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040573 Catalog Number : 27-03916

Device Description : Reamer 16 mm konvex AO

Device Class : 1

Duns Number: 312546955

Premarket Exempt : No

Product Code : HTO

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040580 Catalog Number : 27-03919

Device Description : Reamer 19 mm konvex AO

Device Class : 1

Duns Number: 312546955

Premarket Exempt : No

Product Code : HTO

Prescription Use : Yes

Device Count : 1

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