FDA.reportPublic FDA data

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

Primary DI
06903195108145
Brand
PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)
Company
Kontour(Xi'An) Medical Technology Co.,Ltd.
Model
KT-T3L6H1
Catalog number
CF26030006
Published
2022-12-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
GXNPlate, Cranioplasty, Preformed, Non-Alterable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06903195108145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06903195108145069031951081456903195108145

GMDN Terms#

Term, Definition table
TermDefinition
Cranioplasty plate, non-alterableAn implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
529652129
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06903195108008PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L9H2CF260200102022-12-08
06903195108015PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L10H2CF260200112022-12-08
06903195108039PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L12H2CF260200132022-12-08
06903195108046PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L13H2CF260200142022-12-08
06903195108053PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L14H2CF260200152022-12-08
06903195108060PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L15H2CF260200162022-12-08
06903195108077PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L16H2CF260200172022-12-08
06903195108084PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T2L17H2CF260200182022-12-08
06903195108091PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L1H1CF260300012022-12-08
06903195108107PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L2H1CF260300022022-12-08
06903195108114PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L3H1CF260300032022-12-08
06903195108121PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L4H1CF260300042022-12-08
06903195108138PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L5H1CF260300052022-12-08
06903195108152PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L7H1CF260300072022-12-08
06903195108169PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L18H1CF260300082022-12-08
06903195108176PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L8H2CF260300092022-12-08
06903195108183PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L9H2CF260300102022-12-08
06903195108190PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L10H2CF260300112022-12-08
06903195108206PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L11H2CF260300122022-12-08
06903195108213PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)KT-T3L12H2CF260300132022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188325457HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-04
00810188325464HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-04
00810188325303HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-26
00810188325372HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-26
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00810188325327HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-19
00810188325334HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-19
00810188325297HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-17
00810188325259HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-07
00810188325266HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-07
00810188325044HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-03
00810188325181HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-03
00810188325204HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-03
00810188325174HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-31
00810188325129HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-28
00810188325105HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-27
00810188325099HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-23
00810188325112HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-23
00810188325068HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-20
00810188325075HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-20
00810188325082HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-20
00810188325051HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-17
00810188324955HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-14
00810188325013HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-14
00810188324795HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13
00810188324948HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13
00810188324986HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-13
00810188324931HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-10
00810188324979HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-10
00810188324924HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-07-09