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

Gown, Surgical (FYA) (4) Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene (NBY) (4) Drape, Surgical (KKX) (1) Unit, Operative Dental, Accessories (NRD) (1)

Premarket Exempt

No Yes

Clear

SURGICAL STERILE DRAPE - 08056646502424 Catalog Number :

Device Description : DRAPE CM 100X150 WITH ADHESIVE U SHAPE CM 6,5X50 - ESSENTIAL LINE

Device Class :

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : Yes

Device Count : 25

ESSENTIAL SURGICAL - 08056646502431 Catalog Number :

Device Description : ESSENTIAL SURGICAL GOWN SMMS 35GR POUCHED - NO HANDTOWELS - SIZE M

Device Class :

Duns Number: 447696675

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 30

ESSENTIAL SURGICAL - 08056646502448 Catalog Number :

Device Description : ESSENTIAL SURGICAL GOWN SMMS 35GR POUCHED - NO HANDTOWELS - SIZE L

Device Class : 2

Duns Number: 447696675

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 30

ESSENTIAL SURGICAL - 08056646502455 Catalog Number :

Device Description : ESSENTIAL SURGICAL GOWN SMMS 35GR POUCHED - NO HANDTOWELS - SIZE XL

Device Class : 2

Duns Number: 447696675

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 30

ESSENTIAL SURGICAL - 08056646502462 Catalog Number :

Device Description : ESSENTIAL SURGICAL GOWN SMMS 35GR POUCHED - NO HANDTOWELS - SIZE XXL

Device Class : 2

Duns Number: 447696675

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 30

OMNISLEEVE - 08056646502561 Catalog Number :

Device Description : sterile and disposable protective barriers in water-repellent TNT, PVC, latex an sterile and disposable protective barriers in water-repellent TNT, PVC, latex and polyurethane for the treatment center, the quiver, the lamp handles, the control panels, the switches, the handpieces, the suction tubes, the end part of the X-rays , cameras, trays and instrument holders, contaminated waste containers, basins and swabs for disinfection.

Device Class :

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : NRD

Prescription Use : No

Device Count : 1

Sterile PTFE Surgical Suture - 08056646503018 Catalog Number :

Device Description : PTFE Suture 60 cm - 3/0 - 19 mm Needle 3/8 - Body Reverse Cutting

Device Class :

Duns Number: 447696675

Premarket Exempt : No

Product Code : NBY

Prescription Use : Yes

Device Count : 12

Sterile PTFE Surgical Suture - 08056646503032 Catalog Number :

Device Description : PTFE Suture 60 cm - 4/0 - 16 mm Needle 3/8 - Body Reverse Cutting

Device Class :

Duns Number: 447696675

Premarket Exempt : No

Product Code : NBY

Prescription Use : Yes

Device Count : 12

Sterile PTFE Surgical Suture - 08056646503056 Catalog Number :

Device Description : PTFE Suture 60 cm - 5/0 - 12 mm Needle 1/2 - Body Reverse Cutting

Device Class :

Duns Number: 447696675

Premarket Exempt : No

Product Code : NBY

Prescription Use : Yes

Device Count : 12

Sterile PTFE Surgical Suture - 08056646503070 Catalog Number :

Device Description : PTFE Suture 60 cm - 5/0 - 12 mm Needle 3/8 - Body Reverse Cutting

Device Class :

Duns Number: 447696675

Premarket Exempt : No

Product Code : NBY

Prescription Use : Yes

Device Count : 12

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