CELLERA LLC

Address:1045 Reed Road,Monroe,OH,45050,US

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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

Dressing, Wound, Occlusive (NAD) (6) Dressing, Wound, Hydrophilic (NAC) (3) Dressing, Wound, Drug (FRO) (1)

Premarket Exempt

No Yes

Clear

Vitale - 00856276008420 Catalog Number : 21290

Device Description : Vitale Sacral Hydrocolloid Dressings, 6" x 7", 1/pouch, 10/box, 10 boxes/case

Device Class : 1

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Vitale - 00856276008444 Catalog Number : 24544

Device Description : Vitale Cover Dressings, 4" x 14", 20/box, 10 boxes/case

Device Class : 1

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Vitale - 00856276008482 Catalog Number : 24504

Device Description : Vitale Cover Dressings, 4" x 4", 30/box, 8 boxes/case

Device Class : 1

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Vitale - 00856276008505 Catalog Number : 21044

Device Description : Vitale Thin Hydrocolloid Dressings, 4" x 4", 1/pouch, 10/box, 10 boxes/case

Device Class : 1

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Vitale - 00856276008529 Catalog Number : 20868

Device Description : Vitale Hydroconductive Dressings, 6" x 8", 1/pouch, 10/box, 10 boxes/case

Device Class : 1

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Vitale - 00856276008543 Catalog Number : 20190

Device Description : Vitale Sacral Silicone Dressings, 1/pouch, 5/box, 40 boxes/case

Device Class : 1

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Vitale - 00856276008574 Catalog Number : 20344

Device Description : Vitale Adhesive Foam Dressings, 4" x 4", 10/box, 10 boxes/case

Device Class : 1

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Vitale - 00856276008598 Catalog Number : 20366

Device Description : Vitale Adhesive Foam Dressings, 6" x 6", 10/box, 10 boxes/case

Device Class : 1

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Vitale - 00856276008611 Catalog Number : 20400

Device Description : Vitale Foam Heel Dressings, 6" x 7", 5/box, 10 boxes/case

Device Class : 1

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Vitale - 00856276008635 Catalog Number :

Device Description : Vitale Calcium Alginate Ropes with Antibacterial Silver, 5/box, 10 boxes/case

Device Class : U

Duns Number: 960091929

Premarket Exempt : No

Product Code : FRO

Prescription Use : No

Device Count : 1

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