OMNIA SRL

Address:Via A. Volta, 7,Mirandola Modena,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) (9) Unit, Oral Irrigation (EFS) (1)

Premarket Exempt

No Yes

Clear

Irrigation line, W&H - 08056646508525 Catalog Number :

Device Description : Y-switches with 3,8 m hose each, (6 pcs)

Device Class : 1

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : EFS

Prescription Use : No

Device Count : 6

Sterile PTFE Surgical Suture - 08056646509232 Catalog Number :

Device Description : PTFE SUTURE - HU-FRIEDY - 45 CM - 3/0 CUTTING 19MM 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 - 08056646509256 Catalog Number :

Device Description : PTFE SUTURE - HU-FRIEDY - 45 CM - 3/0 CUTTING 16MM 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 - 08056646509270 Catalog Number :

Device Description : PTFE SUTURE - HU-FRIEDY - 45 CM - 4/0 CUTTING 19MM 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 - 08056646509294 Catalog Number :

Device Description : PTFE SUTURE - HU-FRIEDY - 45 CM - 4/0 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 - 08056646509317 Catalog Number :

Device Description : PTFE SUTURE - HU-FRIEDY - 45 CM - 4/0 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

Sterile PTFE Surgical Suture - 08056646509331 Catalog Number :

Device Description : PTFE SUTURE - HU-FRIEDY - 45 CM - 4/0 CUTTING 16MM 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 - 08056646509355 Catalog Number :

Device Description : PTFE SUTURE - HU-FRIEDY - 45 CM - 5/0 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 - 08056646509379 Catalog Number :

Device Description : PTFE SUTURE - HU-FRIEDY - 45 CM - 5/0 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 - 08056646509393 Catalog Number :

Device Description : PTFE SUTURE - HU-FRIEDY - 45 CM - 5/0 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

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