FDA.reportPublic FDA data

CODMAN MALIS

Primary DI
10886704015451
Brand
CODMAN MALIS
Company
Cerenovus, Inc.
Model
43-1022
Catalog number
431022
Device description
CODMAN MALIS Titanium Mesh 6 Inches x 6 Inches x .010 Inch (15cm x 15cm x .025cm)
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
GWOPlate, cranioplasty, preformed, alterable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWOPlate, Cranioplasty, Preformed, AlterableNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886704015451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670401545110886704015451

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, metallicA sterile flat woven/knitted material made of a biocompatible metal (e.g., surgical stainless steel, tantalum) with appropriate mechanical characteristics for implantation. This non-dedicated device is used alone or in combination with synthetic materials (e.g., polymers) to support or protect tissues in reconstructive surgical procedures (e.g., to repair large chest wall defects or large abdominal incisional hernias) and/or orthopaedic procedures (e.g., cranioplasty, femoral reconstruction). Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810228570571CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-15
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00810228570595CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570601FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-15
00810228570540CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
00810228570557CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
00810228570564CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-07
00810228570519CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570526FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570533CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-10-01
00810228570465FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570472CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570489CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570496FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570502FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-28
00810228570458CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-21
00810228570373CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570380CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570397FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570403CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-09-18
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00810228570427FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570434FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570441FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-09-18
00810228570137CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-08-17
00810228570144FUSION SKULL IMPLANTKELYNIAM GLOBAL, INC.GWO2026-08-17
00810228570151CUSTOMIZED SKULL IMPLANT (CSI)KELYNIAM GLOBAL, INC.GWO2026-08-17