Corning Incorporated

Address:Av. Ind. del Norte S/N Lote 1 Manzana 7 Parque Ind. del Nort,Reynosa Tamaulipas,MX

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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

DISH, TISSUE CULTURE (KIZ) (4) Labware, Assisted Reproduction (MQK) (3) Flask, tissue culture (KJA) (2) Labware, assisted reproduction, exempt (PUD) (1)

Premarket Exempt

No Yes

Clear

Falcon - 20389151000010 Catalog Number : 353653

Device Description : Falcon® 60 x 15 mm IVF One Well Dish Tested for Embryotoxicity

Device Class :

Duns Number: 001307735

Premarket Exempt : No

Product Code : MQK

Prescription Use : No

Device Count : 20

Falcon - 20389151000027 Catalog Number : 353654

Device Description : Falcon® In Vitro Fertilization 4 Well Plate Tested for Embryotoxicity

Device Class : 2

Duns Number: 001307735

Premarket Exempt : No

Product Code : MQK

Prescription Use : No

Device Count : 1

Falcon - 20389151000034 Catalog Number : 353655

Device Description : Falcon® 50 x 9 mm IVF Low Wall Dish Tested for Embryotoxicity

Device Class :

Duns Number: 001307735

Premarket Exempt : No

Product Code : MQK

Prescription Use : No

Device Count : 4

Corning® - 20389151000041 Catalog Number : 353671

Device Description : Dish 4 Well TC IVF Flat Lid, Sterile

Device Class : 2

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : PUD

Prescription Use : No

Device Count : 1

Corning® PureCoat™ - 20389151000188 Catalog Number : 356717

Device Description : Amine 96 Well Black/Clear Flat Bottom Plate, 5/Pack, 50/Case

Device Class :

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KIZ

Prescription Use : No

Device Count : 5

Corning® PureCoat™ - 20389151000195 Catalog Number : 356719

Device Description : Amine 384 Well Black Plate, 5/Pack, 50/Case

Device Class :

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KIZ

Prescription Use : No

Device Count : 5

Corning® PureCoat™ - 20389151000201 Catalog Number : 356721

Device Description : Amine 6 Well Plate, 5/Pack, 50/Case

Device Class :

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KIZ

Prescription Use : No

Device Count : 5

Corning® PureCoat™ - 20389151000218 Catalog Number : 356723

Device Description : Amine 24 Well TC-Treated Plate, 5/Pack, 50/Case

Device Class :

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KIZ

Prescription Use : No

Device Count : 5

Corning® PureCoat™ - 20389151000225 Catalog Number : 356726

Device Description : Amine 75cm2 Rectangular Canted Neck Cell Culture Flask with Vented Cap

Device Class :

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KJA

Prescription Use : No

Device Count : 5

Corning® PureCoat™ - 20389151000232 Catalog Number : 356728

Device Description : Amine 175cm2 Rectangular Straight Neck Cell Culture Flask with Vented Cap

Device Class :

Duns Number: 001307735

Premarket Exempt : Yes

Product Code : KJA

Prescription Use : No

Device Count : 5

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