FDA.reportPublic FDA data

Corning® PureCoat™

Primary DI
20389151000164
Brand
Corning® PureCoat™
Company
CORNING INCORPORATED
Model
354780
Catalog number
354780
Device description
Carboxyl 175cm2 Rectangular Straight Neck Cell Culture Flask with Vented Cap
Published
2019-04-26
Public version status
Update
Distribution status
Not 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
KJAFlask, tissue culture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJAFlask, Tissue CultureHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20389151000164PrimaryGS10
10389151000167Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2038915100016420389151000164
1038915100016710389151000167

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area0

Contacts#

Phone, Email table
PhoneEmail
+1(800)492-1110scientificsupport@corning.com

Regulatory Flags#

DUNS number
783670318
Device count
5
DM exempt
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
20389151000157Corning® PureCoat™3547783547782019-04-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
H108118781CorningCorning IncorporatedKJA2025-01-22
H108112001CorningCorning IncorporatedKJA2024-12-23
H108117601CorningCorning IncorporatedKJA2024-07-25
H108117611CorningCorning IncorporatedKJA2024-07-25
H108117621CorningCorning IncorporatedKJA2024-07-25
H108117571CorningCorning IncorporatedKJA2024-01-18
H108117581CorningCorning IncorporatedKJA2023-12-01
H108117591CorningCorning IncorporatedKJA2023-12-01
H108117651CorningCorning IncorporatedKJA2023-10-09
H108117661CorningCorning IncorporatedKJA2023-10-09
H108117641CorningCorning IncorporatedKJA2023-09-21