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

Drape, Surgical (KKX) (7) Mask, Surgical (FXX) (3)

Premarket Exempt

No Yes

Clear

FACE MASKS - 08056646501403 Catalog Number :

Device Description : 3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - ORANGE

Device Class :

Duns Number: 447696675

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 50

FACE MASKS - 08056646501427 Catalog Number :

Device Description : 3-LAYER FACE MASK WITH ROUND, ELASTICATED EAR LOOPS - PURPLE

Device Class :

Duns Number: 447696675

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 50

FACE MASKS - 08056646501441 Catalog Number :

Device Description : 3-LAYER FACE MASK WITH SPLASHGUARD VISOR AND ELASTIC BANDS - LIGHT BLUE

Device Class :

Duns Number: 447696675

Premarket Exempt : No

Product Code : FXX

Prescription Use : Yes

Device Count : 50

SURGICAL STERILE DRAPE - 08056646501465 Catalog Number :

Device Description : ABSORBENT/LIQUID PROOF DRAPE - CM 50X50 - PE and NON WOVEN FABRIC - BLUE

Device Class :

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : Yes

Device Count : 125

SURGICAL STERILE DRAPE - 08056646501489 Catalog Number :

Device Description : ABSORBENT/LIQUID PROOF DRAPE - CM 50X75 - PE and NON WOVEN FABRIC - BLUE

Device Class :

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : Yes

Device Count : 100

SURGICAL STERILE DRAPE - 08056646501502 Catalog Number :

Device Description : ABSORBENT/LIQUID PROOF DRAPE - CM 75X90 - PE and NON WOVEN FABRIC - BLUE

Device Class :

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : Yes

Device Count : 50

SURGICAL STERILE DRAPE - 08056646501526 Catalog Number :

Device Description : ABSORBENT/LIQUID PROOF DRAPE - CM 100X150 - PE and NON WOVEN FABRIC - BLUE

Device Class :

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : Yes

Device Count : 25

SURGICAL STERILE DRAPE - 08056646501540 Catalog Number :

Device Description : ABSORBENT/LIQUID PROOF DRAPE - CM 150X200 - PE and NON WOVEN FABRIC - BLUE

Device Class :

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : Yes

Device Count : 25

SURGICAL STERILE DRAPE - 08056646501564 Catalog Number :

Device Description : LIQUID REPELLENT DRAPE CM 67X75 - SONTARA - BLUE

Device Class :

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : Yes

Device Count : 25

SURGICAL STERILE DRAPE - 08056646501588 Catalog Number :

Device Description : LIQUID REPELLENT DRAPE CM 75X100 - SONTARA - BLUE

Device Class :

Duns Number: 447696675

Premarket Exempt : Yes

Product Code : KKX

Prescription Use : Yes

Device Count : 40

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