Corning Incorporated

Address:1 BECTON CIR,Durham,NC,27712,US

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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

Flask, tissue culture (KJA) (10)

Premarket Exempt

No Yes

Clear

Corning® PureCoat™ - 20389151000508 Catalog Number : 356291

Device Description : Recombinant Laminin-521, Human, 75cm2 Flask

Device Class : 1

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KJA

Prescription Use : No

Device Count : 1

Corning® PureCoat™ - 20389151000515 Catalog Number : 356292

Device Description : Recombinant Laminin-521, Human, 175cm2 Flask

Device Class : 1

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KJA

Prescription Use : No

Device Count : 1

Corning® PureCoat™ - 20389151000522 Catalog Number : 356293

Device Description : Recombinant Laminin-521, Human, 3 Multi-Layer Flask

Device Class : 1

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KJA

Prescription Use : No

Device Count : 1

Corning® PureCoat™ - 20389151000539 Catalog Number : 356294

Device Description : Recombinant Laminin-521, Human, 5 Multi-Layer Flask

Device Class : 1

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KJA

Prescription Use : No

Device Count : 1

PureCoat - 20389151000669 Catalog Number : 356276

Device Description : PureCoat ECM Mimetic Collagen I Peptide 100mm Dish (40 devices total in outer case)

Device Class :

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KJA

Prescription Use : No

Device Count : 5

Corning - H108100121 Catalog Number : 10012

Device Description : Corning HYPERStack 12-Layer Cell Culture Vessel, CellBIND treated Growth Surface Corning HYPERStack 12-Layer Cell Culture Vessel, CellBIND treated Growth Surface, Sterile, 1 per bag, 4 per case

Device Class : 1

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KJA

Prescription Use : No

Device Count : 1

Corning - H108100131 Catalog Number : 10013

Device Description : Corning HYPERStack 12-Layer Cell Culture Vessel, Non-treated (Gamma) Growth Surf Corning HYPERStack 12-Layer Cell Culture Vessel, Non-treated (Gamma) Growth Surface, Sterile, 1 per bag, 4 per case

Device Class : 1

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KJA

Prescription Use : No

Device Count : 1

Corning - H108100201 Catalog Number : 10020

Device Description : Corning CellBIND Surface HYPERFlask M Cell Culture Vessel, Treated, Sterile, Bar Corning CellBIND Surface HYPERFlask M Cell Culture Vessel, Treated, Sterile, Bar Coded, 4 per Bag, 4 per Case

Device Class :

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KJA

Prescription Use : No

Device Count : 4

Corning - H108100241 Catalog Number : 10024

Device Description : Corning CellBIND Surface HYPERFlask Cell Culture Vessel, Treated, Sterile, Bar C Corning CellBIND Surface HYPERFlask Cell Culture Vessel, Treated, Sterile, Bar Coded, 4 per Bag, 24 per Case

Device Class :

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KJA

Prescription Use : No

Device Count : 4

Corning - H108100301 Catalog Number : 10030

Device Class : 1

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KJA

Prescription Use : No

Device Count : 1

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