FDA.reportPublic FDA data

Corning

Primary DI
H108217761
Brand
Corning
Company
Corning Incorporated
Model
21776
Catalog number
21776
Device description
Corning HYPERStack, 36-Layer, CellBIND treated surface, with accessory and filter, Sterile, 1 per bag, 2 per case
Published
2022-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
H108217761PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
001307735
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H108112101Corning11210112102020-12-02
H108112331Corning11233112332020-12-02
H108112401Corning11240112402020-12-02
H108112501Corning11250112502020-12-02
H10832021Corning320232022020-12-02
H10846261Corning462646262020-12-02
H10846271Corning462746272020-12-02
H10846281Corning462846282020-12-02
H10846291Corning462946292020-12-02
H10871131Corning711371132020-12-02
H10871141Corning711471142020-12-02
H10872011Corning720172012020-12-02
H1084311781Corning4311784311782020-10-01
H1084311791Corning4311794311792020-10-01
H108118191Corning11819118192026-07-29
H108118201Corning11820118202026-07-29
H10839751Corning397539752026-07-29
H10839991Corning399939992026-07-29
H108118141Corning11814118142026-07-08
H108118181Corning11818118182026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H108118191CorningCorning IncorporatedKJA2026-07-29
H108118201CorningCorning IncorporatedKJA2026-07-29
H10839751CorningCorning IncorporatedKJA2026-07-29
H10839991CorningCorning IncorporatedKJA2026-07-29
H108118141CorningCorning IncorporatedKJA2026-07-08
H108118181CorningCorning IncorporatedKJA2026-07-08
H108118211CorningCorning IncorporatedKJA2026-07-08
H108118241CorningCorning IncorporatedKJA2026-07-08
H108118341CorningCorning IncorporatedKJA2026-07-08
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
H108112001CorningCorning IncorporatedKJA2024-12-23
H108117601CorningCorning IncorporatedKJA2024-07-25