FDA.reportPublic FDA data

Corning

Primary DI
H10836451
Brand
Corning
Company
Corning Incorporated
Model
3645
Catalog number
3645
Device description
Corning 3L Disposable Spinner Flask without Impeller, assembled with customized transfer cap, Lonza SG, 1per pack, 2 per case
Published
2020-12-02
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
KJESPINNER SYSTEM, CELL CULTURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJESpinner System, Cell CultureHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H10836453PackageHIBCC2In Commercial Distribution
H10836451PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Blood/tissue storage/culture containerA receptacle 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. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
001307735
Device count
1
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
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
20389151000386Corning® PureCoat™3562443562442019-04-26
20389151000478Corning® PureCoat™3562743562742019-04-26
20389151000119Corning® PureCoat™3547323547322019-04-26
20389151000133Corning® PureCoat™3547733547732019-04-26
20389151000140Corning® PureCoat™3547753547752019-04-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H10835151CorningCorning IncorporatedKJE2026-06-05
H108119151CorningCorning IncorporatedKJE2020-12-02
H108119161CorningCorning IncorporatedKJE2020-12-02
H108119171CorningCorning IncorporatedKJE2020-12-02
H108130061CorningCorning IncorporatedKJE2020-12-02
H108130071CorningCorning IncorporatedKJE2020-12-02
H108130091CorningCorning IncorporatedKJE2020-12-02
H10835281CorningCorning IncorporatedKJE2020-12-02
H10835451CorningCorning IncorporatedKJE2020-12-02
H10835461CorningCorning IncorporatedKJE2020-12-02
H10835581CorningCorning IncorporatedKJE2020-12-02
H10835591CorningCorning IncorporatedKJE2020-12-02
H10835611CorningCorning IncorporatedKJE2020-12-02
H10835621CorningCorning IncorporatedKJE2020-12-02
H10835631CorningCorning IncorporatedKJE2020-12-02
H10835641CorningCorning IncorporatedKJE2020-12-02
H10835651CorningCorning IncorporatedKJE2020-12-02
H10835691CorningCorning IncorporatedKJE2020-12-02
H10835791CorningCorning IncorporatedKJE2020-12-02
H10835801CorningCorning IncorporatedKJE2020-12-02
H10835811CorningCorning IncorporatedKJE2020-12-02
H10871741CorningCorning IncorporatedKJE2020-12-02
H108119153CorningCORNING INCORPORATEDKJE2020-12-02
H108119163CorningCORNING INCORPORATEDKJE2020-12-02
H108119173CorningCORNING INCORPORATEDKJE2020-12-02
H108130063CorningCORNING INCORPORATEDKJE2020-12-02
H108130073CorningCORNING INCORPORATEDKJE2020-12-02
H108130093CorningCORNING INCORPORATEDKJE2020-12-02
H10835283CorningCORNING INCORPORATEDKJE2020-12-02
H10835453CorningCORNING INCORPORATEDKJE2020-12-02