FDA.reportPublic FDA data

CRANIOPLASTIC

Primary DI
10886704015505
Brand
CRANIOPLASTIC
Company
Cerenovus, Inc.
Model
43-1280
Catalog number
431280
Device description
Codman CRANIOPLASTIC Resinous Material for Repairing Cranial Defects
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
GXPMETHYL METHACRYLATE FOR CRANIOPLASTY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXPMethyl Methacrylate For CranioplastyNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704015505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670401550510886704015505

GMDN Terms#

Term, Definition table
TermDefinition
Cranial resinous compoundA substance used to reconstitute cranial bone after neurosurgery (i.e., cranioplasty). It typically consists of a self-curing resin [e.g., polymethylmethacrylate (PMMA)] or a two part resinous material made of several compositions. It may be conformed as an inert implant in an appropriate shape (e.g., a plate) needed to repair the defect of the skull, either using an intraoperatively cured solid composition, or a preoperatively fabricated, porous, custom-made, implant. After application, this device cannot be reused.

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
10886704074892ENVOY778-258-00B77825800B2026-09-19
10886704088097CEREGLIDECS71125UCS71125U2025-10-13
10886704088103CEREGLIDECS71115UCS71115U2025-10-13
10886704088110CEREGLIDECS71137UCS71137U2025-10-13
10886704088141CEREGLIDECS71132UCS71132U2025-10-13
10886704086437CEREGLIDENIC42132UNIC42132U2025-09-26
10886704086451CEREGLIDENIC42144UNIC42144U2025-09-26
10886704086475CEREGLIDENIC42160UNIC42160U2025-09-26
10886704086499CEREGLIDENIC57115UNIC57115U2025-09-26
10886704086512CEREGLIDENIC57125UNIC57125U2025-09-26
10886704086536CEREGLIDENIC57132UNIC57132U2025-09-26
10886704086550CEREGLIDENIC57137UNIC57137U2025-09-26
10886704086598CEREGLIDENIC42125U2025-09-26
10886704086611CEREGLIDENIC42115U2025-09-26
10886704088073CEREGLIDENIC42152UNIC42152U2025-09-26
10886704086017CEREGLIDESBC92114UGSBC92114UG2024-06-20
10886704086048CEREGLIDESBC92122UGSBC92122UG2024-06-20
10886704086079CEREGLIDESBC92130UGSBC92130UG2024-06-20
10886704086109CEREGLIDESBC92135UGSBC92135UG2024-06-20
10886704085355CEREGLIDENIC71115UNIC71115U2023-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800065231270TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231287TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231812TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231829TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231836TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231843TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231850TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231867TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231874TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231881TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231898TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231904TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231911TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231928TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231935TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231942TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231959TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231966TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231973TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231980TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065231997TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065232000TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065232017TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065232024TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065232031TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
08800065232048TnR Cranial ImplantT&R BIOFAB CO.,LTDGXP2026-08-24
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.GXP2026-06-05
00850391007245Montage Settable Bone PuttyABYRX, INC.GXP2023-11-16
00850391007252Montage Settable Bone PuttyABYRX, INC.GXP2023-11-16
08885013201307OsteoplugOSTEOPORE INTERNATIONAL PTE. LTD.GXP2023-08-02