FDA.report

IPS

Primary DI
00888118100375
Brand
IPS
Company
KLS-Martin L.P.
Model
60-000-35-09
Device description
IMPLANT, CRANIAL, ONLAY, 00035, 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
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GXNPLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Product Code Classifications

CodeDeviceSpecialtyClass
GXNPlate, Cranioplasty, Preformed, Non-AlterableNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888118100375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118100375008881181003758881181003750888118100375

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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

Regulatory Flags

DUNS number
826499238
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00888118131782LEVEL ONE EXTREMITY26-066-60-092026-05-25
00888118131799LEVEL ONE EXTREMITY26-066-70-092026-05-25
00888118144928LEVEL ONE EXTREMITY26-950-40-072026-05-25
00888118145284PURE PECTUS24-070-60-092026-05-25
00888118145291PURE PECTUS24-070-62-092026-05-25
00888118150240PURE PECTUSCTM-241-100-012026-05-25
00888118150257PURE PECTUSCTM-241-101-012026-05-25
00888118150264PURE PECTUSCTM-241-200-012026-05-25
00888118150448IXOSCTM-263-100-012026-05-25
00888118150455IXOSCTM-263-101-012026-05-25
00888118150462IXOSCTM-263-202-012026-05-25
00888118150479IXOSCTM-263-202-022026-05-25
00888118150486IXOSCTM-263-202-032026-05-25
00888118150493IXOSCTM-263-202-042026-05-25
00888118150646IPS60-011-42-09-LP2026-05-25
00888118153029L1 STERNALCTM-242-302-012026-05-25
00888118153050IXOSCTM-263-203-012026-05-25
00888118153067IXOSCTM-263-203-022026-05-25
00888118153074IXOSCTM-263-203-032026-05-25
00888118153081IXOSCTM-263-203-042026-05-25

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