Corning Medical Devices

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Device Class

Class- (None) Class-1 (A medical device with low to moderate risk that requires general controls)

Product Code

CONTAINER, SPECIMEN, STERILE (FMH) (8) FORMULATIONS, BALANCED SALT SOLUTIONS (KIP) (1) MEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE (KIT) (1) DISH, TISSUE CULTURE (KIZ) (10) Flask, Tissue Culture (KJA) (3) Flask, tissue culture (KJA) (339) BOTTLE, ROLLER, TISSUE CULTURE (KJC) (44) SPINNER, FLASK (KJD) (12) SPINNER SYSTEM, CELL CULTURE (KJE) (17) SYSTEM, SUSPENSION, CELL CULTURE (KJF) (17) EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE (LXG) (15)

Premarket Exempt

Yes

Clear

Corning Incorporated - H10875251 Catalog Number : 7525

Device Description : TRANSWELL,100CM2,0.4UM,PC,MCB1

Device Class :

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KIZ

Prescription Use : No

Device Count : 5

Corning Incorporated - H108118081 Catalog Number : 11808

Device Description : Erl, 1L, ATC, 1/bag 4/case

Device Class : 1

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KJA

Prescription Use : No

Device Count : 1

MEDIATECH, INC. - H10840215CV1 Catalog Number : 40-215-CV

Device Description : Corning® 500 mL hybrigro SF™

Device Class :

Duns Number: 181302050

Premarket Exempt : Yes

Product Code : KIT

Prescription Use : No

Device Count : 6

MEDIATECH, INC. - H10820021CV1 Catalog Number : 20-021-CV

Device Description : Corning® 500 mL HBSS (Hanks Balanced Salt Solution), 10x [-] sodium bicarbonate, Corning® 500 mL HBSS (Hanks Balanced Salt Solution), 10x [-] sodium bicarbonate, calcium, magnesium

Device Class :

Duns Number: 181302050

Premarket Exempt : Yes

Product Code : KIP

Prescription Use : No

Device Count : 6

Corning Incorporated - H10869233 Catalog Number : 6923

Device Description : Corning X-Balance Ring Kit

Device Class : 1

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 1

Corning Incorporated - H10869203 Catalog Number : 6920

Device Description : Corning X-Counterweight High (Accessories)

Device Class : 1

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 1

Corning Incorporated - H10899991 Catalog Number : 9999

Device Description : CellSTACK,5-STACK,W/UNIVERSAL

Device Class : 1

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KJA

Prescription Use : No

Device Count : 1

Corning Incorporated - H10899941 Catalog Number : 9994

Device Description : CellSTACK Chamber,40-STACK,W/U

Device Class : 1

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KJA

Prescription Use : No

Device Count : 1

Corning Incorporated - H10899881 Catalog Number : 9988

Device Description : CellSTACK Chamber,10-STACK,W/U

Device Class : 1

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KJA

Prescription Use : No

Device Count : 1

Corning Incorporated - H10899841 Catalog Number : 9984

Device Description : CellSTACK,2-STACK,W/UNIVERSAL

Device Class : 1

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KJA

Prescription Use : No

Device Count : 1

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