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) (5) Dressing, Wound, Drug (FRO) (3) Dressing, Wound, Collagen (KGN) (2)

Premarket Exempt

No Yes

Clear

Vitale - 00850005565420 Catalog Number : 22044

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

Device Class :

Duns Number: 960091929

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

Vitale - 00850005565444 Catalog Number : 22077

Device Description : Vitale Collagen Dressings, 7" x 7", 10/box, 10 boxes/case

Device Class :

Duns Number: 960091929

Premarket Exempt : No

Product Code : KGN

Prescription Use : Yes

Device Count : 1

Vitale STRONG - 00850005565468 Catalog Number : 20650

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

Device Class :

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Vitale STRONG - 00850005565499 Catalog Number : 20652

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

Device Class :

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Vitale STRONG - 00850005565512 Catalog Number : 20654

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

Device Class :

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Vitale STRONG - 00850005565543 Catalog Number : 20655

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

Device Class :

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Vitale STRONG - 00850005565567 Catalog Number : 20658

Device Description : Calcium Alginate Dressings, 4" x 8", 5/box, 10 boxes/case

Device Class :

Duns Number: 960091929

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Vitale STRONG - 00850005565703 Catalog Number : 20550

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

Device Class :

Duns Number: 960091929

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

Vitale STRONG - 00850005565734 Catalog Number : 20552

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

Device Class :

Duns Number: 960091929

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

Vitale STRONG - 00850005565758 Catalog Number : 20555

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

Device Class :

Duns Number: 960091929

Premarket Exempt : No

Product Code : FRO

Prescription Use : Yes

Device Count : 1

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