FDA.reportPublic FDA data

Corning

Primary DI
H108116563
Brand
Corning
Company
CORNING INCORPORATED
Model
11656
Catalog number
11656
Device description
STORAGE BOTTLE,250ML,PS,W/ACCE
Published
2020-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
H108116563PackageHIBCC6In Commercial Distribution
H108116561PrimaryHIBCC0

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
001111103
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
20389151000164Corning® PureCoat™3547803547802019-04-26
20389151000171Corning® PureCoat™3547843547842019-04-26
H108118251Corning11825118252026-04-01
H108110901Corning11090110902026-02-26
H108110961Corning11096110962026-02-26
H108117801Corning11780117802026-02-26
H108119771Corning11977119772026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H1084317061CorningCorning IncorporatedKJC2025-09-30
07640138981012RegenETREGEN LAB SAKJC2022-06-28
H108116101CorningCorning IncorporatedKJC2022-04-19
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
H108116551CorningCorning IncorporatedKJC2020-12-02
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
H108116653CorningCORNING INCORPORATEDKJC2020-12-02
H108116663CorningCORNING INCORPORATEDKJC2020-12-02
H108116803CorningCORNING INCORPORATEDKJC2020-12-02
H108116813CorningCORNING INCORPORATEDKJC2020-12-02