FDA.report

Kelynaim CSI

Primary DI
00817580021464
Brand
Kelynaim CSI
Company
KELYNIAM GLOBAL, INC.
Model
PEEK-IM1004
Catalog number
PEEK-IM1004
Device description
PEEK Customized Cranial Implant, X-Large
Published
2016-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GXNPlate, Cranioplasty, Preformed, Non-Alterable

Product Code Classifications

CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817580021464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817580021464008175800214648175800214640817580021464

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
785088829
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810125929274KELYNIAM CSIPEEK-IM1004PEEK-IM10042026-03-23
00810125929281KELYNIAM CSIPEEK-IM1001PEEK-IM10012026-03-23
00810125929229KELYNIAM CSIPEEK-IM1004PEEK-IM10042026-03-20
00810125929236KELYNIAM CSIPEEK-IM1004PEEK-IM10042026-03-20
00810125929243KELYNIAM CSIPEEK-IM1003PEEK-IM10032026-03-20
00810125929250KELYNIAM CSIPEEK-IM1003PEEK-IM10032026-03-20
00810125929267KELYNIAM CSIPEEK-IM1004PEEK-IM10042026-03-20
00810125929168KELYNIAM CSIPEEK-IM1004PEEK-IM10042026-03-16
00810125929175KELYNIAM CSIPEEK-IM1004PEEK-IM10042026-03-16
00810125929182KELYNIAM CSIPEEK-IM2003PEEK-IM20032026-03-16
00810125929199KELYNIAM CSIPEEK-IM1004PEEK-IM10042026-03-16
00810125929205KELYNIAM CSIPEEK-IM1004PEEK-IM10042026-03-16
00810125929212KELYNIAM CSIPEEK-IM1004PEEK-IM10042026-03-16
00810125929045KELYNIAM CSIPEEK-IM1001PEEK-IM10012026-03-06
00810125929052KELYNIAM CSIPEEK-IM1004PEEK-IM10042026-03-06
00810125929069KELYNIAM CSIPEEK-IM1001PEEK-IM10012026-03-06
00810125929076KELYNIAM CSIPEEK-IM1004PEEK-IM10042026-03-06
00810125929083KELYNIAM CSIPEEK-IM1004PEEK-IM10042026-03-06
00810125929090KELYNIAM CSIPEEK-IM1001PEEK-IM10012026-03-06
00810125929106KELYNIAM CSIPEEK-IM1004PEEK-IM10042026-03-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810188324511HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-26
00810188324603HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-26
00810188324627HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-26
00810188324573HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-22
00810188324597HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-05-22
00810188323767HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-24
00810188323866HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-24
00810188323873HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-24
00810125929274KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-23
00810125929281KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-23
00810188323552HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-23
00810188323859HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-23
00810125929229KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-20
00810125929236KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-20
00810125929243KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-20
00810125929250KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-20
00810125929267KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-20
00810188323828HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-20
00810188323811HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-19
00810188323835HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-19
00810188323750HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-17
00810125929168KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810125929175KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810125929182KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810125929199KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810125929205KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810125929212KELYNIAM CSIKELYNIAM GLOBAL, INC.GXN2026-03-16
00810188323712HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-13
00810188323736HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-13
00810188323743HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-03-13