FDA.reportPublic FDA data

Corning

Primary DI
H108119163
Brand
Corning
Company
CORNING INCORPORATED
Model
11916
Catalog number
11916
Device description
Corning 3L DSF Custom ATC S
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
KJDSPINNER, FLASK
KJESPINNER SYSTEM, CELL CULTURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJDSpinner, FlaskHematology1
KJESpinner System, Cell CultureHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H108119163PackageHIBCC2In Commercial Distribution
H108119161PrimaryHIBCC0

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
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
H10831521CorningCorning IncorporatedKJD2020-12-02
H10831531CorningCorning IncorporatedKJD2020-12-02
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
H10835671CorningCorning IncorporatedKJD2020-12-02
H10835681CorningCorning IncorporatedKJD2020-12-02
H10835691CorningCorning IncorporatedKJE2020-12-02
H10835781CorningCorning IncorporatedKJD2020-12-02
H10835791CorningCorning IncorporatedKJE2020-12-02
H10835801CorningCorning IncorporatedKJE2020-12-02
H10835811CorningCorning IncorporatedKJE2020-12-02
H10836451CorningCorning IncorporatedKJE2020-12-02
H10837331CorningCorning IncorporatedKJD2020-12-02
H10837341CorningCorning IncorporatedKJD2020-12-02
H10871741CorningCorning IncorporatedKJE2020-12-02