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 - B492201660 Catalog Number : 20166

Device Description : Vitale Silicone Foam Dressings, 6"x6", 10/box, 10 boxes/case, 4 cases/overpack

Device Class :

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Vitale - B492201900 Catalog Number : 20190

Device Description : Vitale Sacral Silicone Foam Dressing, 7" x 6 3/4", 5/box, 10 boxes/case

Device Class :

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Vitale - B492202340 Catalog Number : 20234

Device Description : Vitale Silicone Super-Absorbent Dressing, 3.5" x 4", 10/box, 10 boxes/case, 4 ca Vitale Silicone Super-Absorbent Dressing, 3.5" x 4", 10/box, 10 boxes/case, 4 cases/overpack

Device Class : 1

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Vitale - B492202670 Catalog Number : 20267

Device Description : Vitale Silicone Super-Absorbent Dressings, 6" x 7", 10/box, 10 boxes/case, 2 cas Vitale Silicone Super-Absorbent Dressings, 6" x 7", 10/box, 10 boxes/case, 2 cases/overpack

Device Class :

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Vitale - B492202800 Catalog Number : 20280

Device Description : Vitale Silicone Super-Absorbent Dressings, 8" x 10", 10/box, 10 boxes/case

Device Class : 1

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Vitale - B492203440 Catalog Number : 20344

Device Description : Vitale Adhesive Foam Dressing, 4"x4", 10/box, 10 boxes/case

Device Class : 1

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Vitale - B492203660 Catalog Number : 20366

Device Description : Vitale Adhesive Foam Dressing, 6"x6", 10/box, 10 boxes/case

Device Class : 1

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Vitale - B492204000 Catalog Number : 20400

Device Description : Vitale Foam Heel Dressings, 5/box, 10 boxes/case

Device Class : 1

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAD

Prescription Use : No

Device Count : 1

Vitale - B492204440 Catalog Number : 20444

Device Description : Vitale Non-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 - B492205000 Catalog Number : 20500

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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