FDA.reportPublic FDA data

Corning

Primary DI
H10831523
Brand
Corning
Company
CORNING INCORPORATED
Model
3152
Catalog number
3152
Device description
Corning 125mL Polystyrene Disposable Spinner Flask with 70mm Top Cap and 2 Angled Sidearms, Sterile,1/bag,12/case
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJDSpinner, FlaskHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H10831523PackageHIBCC12In Commercial Distribution
H10831521PrimaryHIBCC0

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
H10831521CorningCorning IncorporatedKJD2020-12-02
H10831531CorningCorning IncorporatedKJD2020-12-02
H10835671CorningCorning IncorporatedKJD2020-12-02
H10835681CorningCorning IncorporatedKJD2020-12-02
H10835781CorningCorning IncorporatedKJD2020-12-02
H10837331CorningCorning IncorporatedKJD2020-12-02
H10837341CorningCorning IncorporatedKJD2020-12-02
H108119153CorningCORNING INCORPORATEDKJD2020-12-02
H108119163CorningCORNING INCORPORATEDKJD2020-12-02
H108119173CorningCORNING INCORPORATEDKJD2020-12-02
H108130063CorningCORNING INCORPORATEDKJD2020-12-02
H108130073CorningCORNING INCORPORATEDKJD2020-12-02
H108130093CorningCORNING INCORPORATEDKJD2020-12-02
H10831533CorningCORNING INCORPORATEDKJD2020-12-02
H10835283CorningCORNING INCORPORATEDKJD2020-12-02
H10835463CorningCORNING INCORPORATEDKJD2020-12-02
H10835593CorningCORNING INCORPORATEDKJD2020-12-02
H10835613CorningCORNING INCORPORATEDKJD2020-12-02
H10835623CorningCORNING INCORPORATEDKJD2020-12-02
H10835633CorningCORNING INCORPORATEDKJD2020-12-02
H10835643CorningCORNING INCORPORATEDKJD2020-12-02
H10835653CorningCORNING INCORPORATEDKJD2020-12-02
H10835673CorningCORNING INCORPORATEDKJD2020-12-02
H10835683CorningCORNING INCORPORATEDKJD2020-12-02
H10835693CorningCORNING INCORPORATEDKJD2020-12-02
H10835783CorningCORNING INCORPORATEDKJD2020-12-02
H10835793CorningCORNING INCORPORATEDKJD2020-12-02
H10835803CorningCORNING INCORPORATEDKJD2020-12-02
H10835813CorningCORNING INCORPORATEDKJD2020-12-02
H10836453CorningCORNING INCORPORATEDKJD2020-12-02