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,Hydrophilic (NAC) (7) Dressing, Wound, Drug (FRO) (3)

Premarket Exempt

Yes No

Clear

Vitale - B492205220 Catalog Number : 20522

Device Description : Vitale Calcium Alginate Dressings with Antibacterial Silver, 2"x2", 10/box, 10 boxes/case

Device Class : U

Duns Number: 960091929

Premarket Exempt : No

Product Code : FRO

Prescription Use : No

Device Count : 1

Vitale - B492205440 Catalog Number : 20544

Device Description : Vitale Calcium Alginate Dressings with Antibacterial Silver, 4"x4", 10/box, 10 boxes/case

Device Class : U

Duns Number: 960091929

Premarket Exempt : No

Product Code : FRO

Prescription Use : No

Device Count : 1

Vitale - B492205450 Catalog Number : 20545

Device Description : Vitale Calcium Alginate Dressings with Antibacterial Silver, 4"x 5", 10/box, 10 boxes/case

Device Class : U

Duns Number: 960091929

Premarket Exempt : No

Product Code : FRO

Prescription Use : No

Device Count : 1

Vitale - B492206000 Catalog Number : 20600

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

Device Class : 1

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Vitale - B492206220 Catalog Number : 20622

Device Description : Vitale Calcium Alginate Dressings, 2" x 2", 10/box, 10 boxes/case

Device Class : 1

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Vitale - B492206440 Catalog Number : 20644

Device Description : Vitale Calcium Alginate Dressings, 4" x 4", 10/box, 10 boxes/case

Device Class : 1

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Vitale - B492206450 Catalog Number : 20645

Device Description : Vitale Calcium Alginate Dressings, 4" x 5", 10/box, 10 boxes/case

Device Class : 1

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Vitale - B492208000 Catalog Number : 20800

Device Description : Vitale Hydroconductive Ropes, 1/pouch, 5/box, 10 boxes/case

Device Class : 1

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Vitale - B492208220 Catalog Number : 20822

Device Description : Vitale Hydroconductive Dressings, 2" x 2", 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 - B492208440 Catalog Number : 20844

Device Description : Vitale Hydroconductive Dressings, 4" x 4", 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

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