FDA.reportPublic FDA data

ANEUROPLASTIC

Primary DI
10886704015512
Brand
ANEUROPLASTIC
Company
Cerenovus, Inc.
Model
43-1290
Catalog number
431290
Device description
Codman ANEUROPLASTIC Resinous Material for Reinforcing and Encapsulating Cerebral
Published
2015-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JXHMETHYL METHACRYLATE FOR ANEURYSMORRHAPHY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXHMethyl Methacrylate For AneurysmorrhaphyNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704015512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670401551210886704015512

GMDN Terms#

Term, Definition table
TermDefinition
Aneurysmorrhaphy tissue adhesiveAn implantable adhesive substance (e.g., a glue or a resin) intended to be used in the repair of an aneurysm by means of obliterative adhesion of the sac.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature025 Degrees Celsius
Special Storage Condition, Specify00Flammable
Special Storage Condition, Specify00Keep away from Sunlight
Storage Environment Temperature025 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
607846297
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886704080428ENPOWERDCB2000500DCB20005002016-09-12
10886704082293CEREBASEGS9090SDGS9090SD2020-04-13
10886704082316CEREBASEGS9080SDGS9080SD2020-04-13
10886704082323CEREBASEGS9095SDGS9095SD2020-04-13
10886704076957DELTAFILLDLF100154DLF1001542016-11-16
10886704076971DELTAFILLDLF100250DLF1002502016-11-16
10886704076988DELTAFILLDLF100258DLF1002582016-11-16
10886704077022DELTAFILLDLF100208DLF1002082016-11-16
10886704077039DELTAFILLDLF100310DLF1003102016-11-16
10886704077046DELTAFILLDLF100308DLF1003082016-11-16
10886704077053DELTAFILLDLF100410DLF1004102015-09-20
10886704077060DELTAFILLDLF100408DLF1004082015-09-20
10886704077077DELTAFILLDLF100510DLF1005102016-11-16
10886704077176DELTAFILLDLF182260DLF1822602016-11-16
10886704077183DELTAFILLDLF182460DLF1824602016-11-16
10886704077244DELTAXSFTDLX100151DLX1001512015-09-20
10886704077251DELTAXSFTDLX100152DLX1001522015-09-20
10886704077268DELTAXSFTDLX100153DLX1001532015-09-20
10886704077275DELTAXSFTDLX100254DLX1002542015-09-20
10886704077282DELTAXSFTDLX100256DLX1002562015-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30014613337911TriageQUIDEL CARDIOVASCULAR INC.JXH2018-11-01