FDA.reportPublic FDA data

Falcon

Primary DI
50389151000592
Brand
Falcon
Company
CORNING INCORPORATED
Model
353143
Catalog number
353143
Device description
Falcon 525cm² Rectangular Straight Neck Cell Culture Multi-Flask, 3-layer with Vented Cap 2/Pack, 12/case
Published
2020-12-29
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
KJAFlask, tissue culture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KJAFlask, Tissue CultureHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50389151000592PackageGS112In Commercial Distribution
10389151000594PrimaryGS10
00389151000597Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038915100059250389151000592
1038915100059410389151000594
00389151000597003891510005973891510005970389151000597

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
783670318
Device count
2
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
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H108112331Corning11233112332020-12-02
H108112401Corning11240112402020-12-02
H108112501Corning11250112502020-12-02
H10832021Corning320232022020-12-02
H10846261Corning462646262020-12-02
H10846271Corning462746272020-12-02
H10846281Corning462846282020-12-02
H10846291Corning462946292020-12-02
H10871131Corning711371132020-12-02
H10871141Corning711471142020-12-02
H10872011Corning720172012020-12-02
H1084311781Corning4311784311782020-10-01
H1084311791Corning4311794311792020-10-01
H108118191Corning11819118192026-07-29
H108118201Corning11820118202026-07-29
H10839751Corning397539752026-07-29
H10839991Corning399939992026-07-29
H108118141Corning11814118142026-07-08
H108118181Corning11818118182026-07-08

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Primary DI, Brand, Company table
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