FDA.reportPublic FDA data

Corning

Primary DI
H108100201
Brand
Corning
Company
Corning Incorporated
Model
10020
Catalog number
10020
Device description
Corning CellBIND Surface HYPERFlask M Cell Culture Vessel, Treated, Sterile, Bar Coded, 4 per Bag, 4 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
KJAFlask, tissue culture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJAFlask, Tissue CultureHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H108100203PackageHIBCC4In Commercial Distribution
H108100201PrimaryHIBCC0
H108100200Unit of UseHIBCC0

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
4
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
20389151000157Corning® PureCoat™3547783547782019-04-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H108117971CorningCorning IncorporatedKJA2026-06-03
H108117981CorningCorning IncorporatedKJA2026-06-03
H108117991CorningCorning IncorporatedKJA2026-06-03
H108118251CorningCorning IncorporatedKJA2026-04-01
H108110901CorningCorning IncorporatedKJA2026-02-26
H108110961CorningCorning IncorporatedKJA2026-02-26
H108117801CorningCorning IncorporatedKJA2026-02-26
H108115131CorningCorning IncorporatedKJA2026-01-05
H108115161CorningCorning IncorporatedKJA2026-01-05
H108115761CorningCorning IncorporatedKJA2026-01-05
H108115041CorningCorning IncorporatedKJA2025-10-28
H108115151CorningCorning IncorporatedKJA2025-10-28
H108115211CorningCorning IncorporatedKJA2025-10-28
H108117091CorningCorning IncorporatedKJA2025-10-28
H108117231CorningCorning IncorporatedKJA2025-10-28
H108117081CorningCorning IncorporatedKJA2025-07-07
H108116301CorningCorning IncorporatedKJA2025-05-15
H108116401CorningCorning IncorporatedKJA2025-05-15
H108115121CorningCorning IncorporatedKJA2025-04-16
H108118781CorningCorning IncorporatedKJA2025-01-22
H108112001CorningCorning IncorporatedKJA2024-12-23
H108117601CorningCorning IncorporatedKJA2024-07-25
H108117611CorningCorning IncorporatedKJA2024-07-25
H108117621CorningCorning IncorporatedKJA2024-07-25
H108117571CorningCorning IncorporatedKJA2024-01-18
H108117581CorningCorning IncorporatedKJA2023-12-01
H108117591CorningCorning IncorporatedKJA2023-12-01
H108117651CorningCorning IncorporatedKJA2023-10-09
H108117661CorningCorning IncorporatedKJA2023-10-09
H108117641CorningCorning IncorporatedKJA2023-09-21