OMNIA SRL

Address:VIA F.DELNEVO 190,FIDENZA Parma,IT

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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

Punch, Biopsy, Surgical (EME) (6) Unit, Oral Irrigation (EFS) (4)

Premarket Exempt

No Yes

Clear

Punches, NOBEL - 08056646504770 Catalog Number :

Device Description : Soft Tissue Punch Ø 4.1 mm, 5-pack

Device Class : 1

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : EME

Prescription Use : No

Device Count : 5

Punches, NOBEL - 08056646504794 Catalog Number :

Device Description : Soft Tissue Punch Ø 5.2 mm, 5-pack

Device Class : 1

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : EME

Prescription Use : No

Device Count : 5

Punches, NOBEL - 08056646504817 Catalog Number :

Device Description : Soft Tissue Punch Ø 6.2 mm, 5-pack

Device Class : 1

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : EME

Prescription Use : No

Device Count : 5

Punches, NOBEL - 08056646504831 Catalog Number :

Device Description : Guided Soft Tissue Punch NP 5/pkg

Device Class : 1

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : EME

Prescription Use : No

Device Count : 5

Punches, NOBEL - 08056646504855 Catalog Number :

Device Description : Guided Soft Tissue Punch RP 5/pkg

Device Class : 1

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : EME

Prescription Use : No

Device Count : 5

Punches, NOBEL - 08056646504879 Catalog Number :

Device Description : Guided Soft Tissue Punch 6.0/WP 5/pkg

Device Class : 1

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : EME

Prescription Use : No

Device Count : 5

Irrigation line, Nobel - 08056646504909 Catalog Number :

Device Description : Hose set for machinery (10/pkg)

Device Class : 1

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : EFS

Prescription Use : No

Device Count : 10

Manual irrigation line, Nobel - 08056646504923 Catalog Number :

Device Description : Omnirrigator (5/pkg)

Device Class : 1

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : EFS

Prescription Use : No

Device Count : 5

Irrigation line, Bien Air - 08056646504947 Catalog Number :

Device Description : Tube set sterile S600 (10/pkg)

Device Class : 1

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : EFS

Prescription Use : No

Device Count : 10

Irrigation line, W&H - 08056646508501 Catalog Number :

Device Description : Y-switches with 2,2 m hose each, (6 pcs)

Device Class : 1

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : EFS

Prescription Use : No

Device Count : 6

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