FDA.reportPublic FDA data

IPS

Primary DI
00888118100030
Brand
IPS
Company
KLS-Martin L.P.
Model
60-000-18-09
Device description
IMPLANT, CRANIAL, 00018, PEEK
Published
2016-11-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXNPLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
GXPMETHYL METHACRYLATE FOR CRANIOPLASTY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2
GXPMethyl Methacrylate For CranioplastyNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118100030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118100030008881181000308881181000300888118100030

GMDN Terms#

Term, Definition table
TermDefinition
Cranial bone prosthesis, custom-madeA sterile implantable device intended to repair a defect of the cranium or mandible that is designed and constructed with specific characteristics (e.g., size, shape, material) as prescribed by a healthcare provider for a specified patient. It is typically manufactured from a three-dimensional (3-D) model based on computed tomography (CT) images and made of plastic [e.g., ultrahigh molecular weight polyethylene (UHMWPE), polyetheretherketone (PEEK)] and/or metal [e.g., titanium (Ti)]. The device may be used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease, or for cosmetic/aesthetic purposes.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
1
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118145819IPS60-011-13-09-LP2026-10-01
00888118145826IPS60-011-14-09-LP2026-10-01
00888118145833IPS60-011-15-09-LP2026-10-01
00888118145840IPS60-011-16-09-LP2026-10-01
00888118145857IPS60-011-17-09-LP2026-10-01
00888118145864IPS60-011-18-09-LP2026-10-01
00888118036261LEVEL ONE CMF25-038-30-092016-03-24
00888118036278LEVEL ONE CMF25-038-35-092016-03-24
00888118036285LEVEL ONE NEURO25-040-25-092016-03-24
00888118036292LEVEL ONE NEURO, STERILE25-040-25-712016-03-23
00888118036339LEVEL ONE CMF25-040-35-092016-03-24
00888118036346LEVEL ONE CMF25-040-40-092016-03-24
00888118036360LEVEL ONE NEURO25-042-02-092016-03-24
00888118036391LEVEL ONE NEURO25-042-05-092016-03-24
00888118036483LEVEL ONE CMF, STERILE25-042-20-712016-03-23
00888118092618LEVEL ONE CMF25-043-06-092016-03-24
00888118155498IPS60-500-15-092026-09-28
00888118155504IPS60-500-15-09-LP2026-09-28
00888118155511IPS60-500-15-09-PP2026-09-28
00888118155528IPS60-500-17-092026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188325709HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-30
00810188325600HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-29
00810188325655HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-28
00810188325594HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-25
00810188325679HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-24
00810188325624HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-21
00810188325631HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-09-21
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
00810188325389HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.GXN2026-08-26
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