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

REAMER (HTO) (4) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (3) INSTRUMENT, CUTTING, ORTHOPEDIC (HTZ) (1) RETRACTOR (GAD) (1) SCREWDRIVER (HXX) (1)

Premarket Exempt

No Yes

Clear

MONDEAL - 04050435040597 Catalog Number : 27-03922

Device Description : Reamer 21 mm konvex AO

Device Class : 1

Duns Number: 312546955

Premarket Exempt : No

Product Code : HTO

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040603 Catalog Number : 27-04016

Device Description : Reamer 16 mm koncave AO

Device Class : 1

Duns Number: 312546955

Premarket Exempt : No

Product Code : HTO

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040610 Catalog Number : 27-04019

Device Description : Reamer 19 mm koncave AO

Device Class : 1

Duns Number: 312546955

Premarket Exempt : No

Product Code : HTO

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040627 Catalog Number : 27-04022

Device Description : Reamer 21 mm koncave AO

Device Class : 1

Duns Number: 312546955

Premarket Exempt : No

Product Code : HTO

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040641 Catalog Number : 27-08022

Device Description : Screwdriver handle medium AO cannulated black

Device Class : 1

Duns Number: 312546955

Premarket Exempt : No

Product Code : HXX

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040665 Catalog Number : 27-08032

Device Description : Forceps for picking up screws

Device Class : 1

Duns Number: 312546955

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040702 Catalog Number : 27-08040

Device Description : Bending lever M1

Device Class : 1

Duns Number: 312546955

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040771 Catalog Number : 27-08060

Device Description : Bending Pliers with pin M2 / M3

Device Class : 1

Duns Number: 312546955

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040795 Catalog Number : 27-08063

Device Description : Saxena Bone Grafting Retractor

Device Class : 1

Duns Number: 312546955

Premarket Exempt : No

Product Code : GAD

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040887 Catalog Number : 27-08120

Device Description : Plate Cutting Forceps M1/M2

Device Class : 1

Duns Number: 312546955

Premarket Exempt : No

Product Code : HTZ

Prescription Use : Yes

Device Count : 1

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