FDA.reportPublic FDA data

Corning

Primary DI
H108116001
Brand
Corning
Company
Corning Incorporated
Model
11600
Catalog number
11600
Device description
Storage Bottle, 500mL, manifol
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
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
H108116003PackageHIBCC1In Commercial Distribution
H108116001PrimaryHIBCC0

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
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
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
H108116563CorningCORNING INCORPORATEDKJC2020-12-02
H108116653CorningCORNING INCORPORATEDKJC2020-12-02
H108116663CorningCORNING INCORPORATEDKJC2020-12-02
H108116803CorningCORNING INCORPORATEDKJC2020-12-02
H108116813CorningCORNING INCORPORATEDKJC2020-12-02