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

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (7) Screw, Fixation, Bone (HWC) (2)

Premarket Exempt

No Yes

Clear

MONDEAL - 04050435118715 Catalog Number : 26-50826

Device Description : MCD Mini DTS Screw 2.5/3.0 x 26 mm self-drilling cannulated grey

Device Class : 2

Duns Number: 312546955

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435118722 Catalog Number : 26-50828

Device Description : MCD Mini DTS Screw 2.5/3.0 x 28 mm self-drilling cannulated grey

Device Class : 2

Duns Number: 312546955

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435135255 Catalog Number : 27-06500

Device Description : Depth comparison instrument for K-Wire 150 mm, M1 / M2 200 mm

Device Class : 1

Duns Number: 312546955

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435135262 Catalog Number : 27-06501

Device Description : Depth comparison instrument for K-Wire150 mm M3 200 mm

Device Class : 1

Duns Number: 312546955

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435135279 Catalog Number : 27-06502

Device Description : Depth comparison instrument for K-Wire200 mm M4 200 mm

Device Class : 1

Duns Number: 312546955

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435135286 Catalog Number : 27-06507

Device Description : Screws and K-Wire comparison plate M1 / M2 / M3 150 mm

Device Class : 1

Duns Number: 312546955

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435135293 Catalog Number : 27-06508

Device Description : Screws and K-Wire comparison plate M4 150 mm

Device Class : 1

Duns Number: 312546955

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435135309 Catalog Number : 27-08034

Device Description : Depth comparison instrument Ø Screw1.7 - 2.5 mm, Ø probe 1.2 mm, M1, Depth comparison instrument Ø Screw1.7 - 2.5 mm, Ø probe 1.2 mm, M1, Range 0 - 50 mm

Device Class : 1

Duns Number: 312546955

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MONDEAL - 04050435135316 Catalog Number : 27-08036

Device Description : Depth comparison instrument Ø Screw2.7 - 3.5 mm, Ø probe 1.7 mm Depth comparison instrument Ø Screw2.7 - 3.5 mm, Ø probe 1.7 mm M2/M3, Range 0 - 80 mm

Device Class : 1

Duns Number: 312546955

Premarket Exempt : No

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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