FDA.reportPublic FDA data

Corning

Primary DI
H1084308511
Brand
Corning
Company
Corning Incorporated
Model
430851
Catalog number
430851
Device description
Corning® 850cm² Polystyrene Roller Bottle with Easy Grip Cap, Sterile,5/Bag, 40/Case
Published
2020-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KJCBOTTLE, ROLLER, TISSUE CULTURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJCBottle, Roller, Tissue CultureHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H1084308513PackageHIBCC8In Commercial Distribution
H1084308511PrimaryHIBCC0
H1084308510Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood/tissue storage/culture containerA durable, sterile plastic container with ports, or glass bottle, intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. The device provides a suitable closed environment to reduce the risk of contamination and, if applicable, for cell growth/viability during storage that may or may not involve freezing. A device intended for cryopreservation is typically designed for long-term storage in a freezing system. A device intended for culture is typically gas permeable and may have an inner surface that enables adherence. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)492-1110scientificsupport@corning.com

Regulatory Flags#

DUNS number
001307735
Device count
5
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H108118141Corning11814118142026-07-08
H108118181Corning11818118182026-07-08
H108118211Corning11821118212026-07-08
H108118241Corning11824118242026-07-08
H108118341Corning11834118342026-07-08
H10835151Corning351535152026-06-05
H108117971Corning11797117972026-06-03
H108117981Corning11798117982026-06-03
H108117991Corning11799117992026-06-03
H108118081Corning11808118082020-12-02
H108118091Corning11809118092020-12-02
H108118101Corning11810118102020-12-02
H10874071Corning740774072022-03-15
20389151000249Corning® PureCoat™3567323567322019-04-26
20389151000263Corning® PureCoat™3567733567732019-04-26
20389151000270Corning® PureCoat™3567753567752019-04-26
20389151000287Corning® PureCoat™3567783567782019-04-26
20389151000300Corning® PureCoat™3567843567842019-04-26
20389151000348Corning® PureCoat™3562403562402019-04-26
20389151000355Corning® PureCoat™3562413562412019-04-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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H108116601CorningCorning IncorporatedKJC2022-04-19
H108116701CorningCorning IncorporatedKJC2022-04-19
H108116103CorningCorning IncorporatedKJC2022-04-19
H108116603CorningCorning IncorporatedKJC2022-04-19
H108116703CorningCorning IncorporatedKJC2022-04-19
H108100431CorningCorning IncorporatedKJC2020-12-02
H108116001CorningCorning IncorporatedKJC2020-12-02
H108116501CorningCorning IncorporatedKJC2020-12-02
H108116511CorningCorning IncorporatedKJC2020-12-02
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H108116561CorningCorning IncorporatedKJC2020-12-02
H108116651CorningCorning IncorporatedKJC2020-12-02
H108116661CorningCorning IncorporatedKJC2020-12-02
H108116801CorningCorning IncorporatedKJC2020-12-02
H108116811CorningCorning IncorporatedKJC2020-12-02
H108116901CorningCorning IncorporatedKJC2020-12-02
H108118001CorningCorning IncorporatedKJC2020-12-02
H108118011CorningCorning IncorporatedKJC2020-12-02
H108100433CorningCORNING INCORPORATEDKJC2020-12-02
H108116003CorningCORNING INCORPORATEDKJC2020-12-02
H108116503CorningCORNING INCORPORATEDKJC2020-12-02
H108116513CorningCORNING INCORPORATEDKJC2020-12-02
H108116553CorningCORNING INCORPORATEDKJC2020-12-02
H108116563CorningCORNING INCORPORATEDKJC2020-12-02
H108116653CorningCORNING INCORPORATEDKJC2020-12-02
H108116663CorningCORNING INCORPORATEDKJC2020-12-02
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