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

Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (NBY) (3) Unit, Oral Irrigation (EFS) (2)

Premarket Exempt

No Yes

Clear

Sterile PTFE Surgical Suture - 08056646509416 Catalog Number :

Device Description : PTFE SUTURE - HU-FRIEDY - 45 CM - 6/0 EXTRA CUTTING 10MM 3/8 CIRCLE REVERSE CUTTING

Device Class : 2

Duns Number: 447696675

Premarket Exempt : No

Product Code : NBY

Prescription Use : Yes

Device Count : 12

Sterile PTFE Surgical Suture - 08056646509430 Catalog Number :

Device Description : PTFE SUTURE - HU-FRIEDY - 45 CM - 6/0 EXTRA CUTTING 12MM 3/8 CIRCLE REVERSE CUTTING

Device Class : 2

Duns Number: 447696675

Premarket Exempt : No

Product Code : NBY

Prescription Use : Yes

Device Count : 12

Sterile PTFE Surgical Suture - 08056646509454 Catalog Number :

Device Description : PTFE SUTURE - HU-FRIEDY - 45 CM - 6/0 CUTTING 12MM 3/8 CIRCLE REVERSE CUTTING

Device Class : 2

Duns Number: 447696675

Premarket Exempt : No

Product Code : NBY

Prescription Use : Yes

Device Count : 12

Infusion Sets, Bien Air - J00715009840101 Catalog Number :

Device Description : Irrigation Line (10/pkg)

Device Class :

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : EFS

Prescription Use : No

Device Count : 10

Infusion Sets, Bien Air - J00715016350101 Catalog Number :

Device Description : Irrigation Line KM (10/pkg)

Device Class : 1

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : EFS

Prescription Use : No

Device Count : 10

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