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

Screw, fixation, bone (HWC) (9) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (1)

Premarket Exempt

No Yes

Clear

MONDEAL - 04050435012716 Catalog Number : 10-60030

Device Description : Plate holding forceps curved 18 cm

Device Class : 1

Duns Number: 312546955

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435039997 Catalog Number : 27-01104

Device Description : 4-hole Plate straight M1 blue

Device Class : 2

Duns Number: 312546955

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040009 Catalog Number : 27-01115

Device Description : 5-hole T-Plate M1 blue

Device Class : 2

Duns Number: 312546955

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040023 Catalog Number : 27-01138

Device Description : 3-hole HT-Plate straight small M1 blue

Device Class : 2

Duns Number: 312546955

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040030 Catalog Number : 27-01140

Device Description : 3-hole HT-Plate straight large M1 blue

Device Class : 2

Duns Number: 312546955

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040047 Catalog Number : 27-01206

Device Description : 6-hole Compression Plate straight M1 blue

Device Class : 2

Duns Number: 312546955

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040061 Catalog Number : 27-01217

Device Description : 7-hole Compression T-Plate M1 blue

Device Class : 2

Duns Number: 312546955

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040078 Catalog Number : 27-01219

Device Description : 9-hole Compression T-Plate M1 blue

Device Class : 2

Duns Number: 312546955

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040191 Catalog Number : 27-02104

Device Description : 4-hole Plate straight M2 gold

Device Class : 2

Duns Number: 312546955

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435040207 Catalog Number : 27-02206

Device Description : 6-hole Compression Plate M2 gold

Device Class : 2

Duns Number: 312546955

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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