FDA.report

IPS

Primary DI
00888118100511
Brand
IPS
Company
KLS-Martin L.P.
Model
60-000-42-09
Device description
IMPLANT, MANDIBLE, ONLAY, 00042, 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
GXPMETHYL METHACRYLATE FOR CRANIOPLASTY

Product Code Classifications

CodeDeviceSpecialtyClass
GXPMethyl Methacrylate For CranioplastyNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888118100511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118100511008881181005118881181005110888118100511

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
00888118143266PURE PECTUS24-070-40-092026-03-23
00888118143273PURE PECTUS24-070-42-092026-03-23
00888118143280PURE PECTUS24-070-44-092026-03-23
00888118143297PURE PECTUS24-070-46-092026-03-23
00888118143303PURE PECTUS24-070-48-092026-03-23
00888118143310PURE PECTUS24-070-50-092026-03-23
00888118143327PURE PECTUS24-071-40-092026-03-23
00888118143334PURE PECTUS24-071-42-092026-03-23
00888118143341PURE PECTUS24-071-44-092026-03-23
00888118143358PURE PECTUS24-071-46-092026-03-23
00888118143365PURE PECTUS24-071-48-092026-03-23
00888118143372PURE PECTUS24-071-50-092026-03-23
00888118145321PURE PECTUS24-070-50-892026-03-23
00888118145338PURE PECTUS24-071-50-892026-03-23
00888118149671LEVEL ONE CMF, STERILE25-882-06-712026-03-23
00888118149701LEVEL ONE CMF, STERILE25-883-17-712026-03-23
00888118149718LEVEL ONE CMF, STERILE25-883-19-712026-03-23
00888118149725LEVEL ONE CMF, STERILE25-887-17-712026-03-23
00888118149732LEVEL ONE CMF, STERILE25-887-19-712026-03-23
00888118149749LEVEL ONE CMF, STERILE25-889-09-712026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00888118150271IPSKLS-Martin L.P.GXP2025-12-23
00850391007450Permatage 10ccABYRX, INC.GXP2025-05-21
00888118144461IPSKLS-Martin L.P.GXP2024-10-08
00888118144478IPSKLS-Martin L.P.GXP2024-10-08
00888118144492IPSKLS-Martin L.P.GXP2024-10-08
00888118144515IPSKLS-Martin L.P.GXP2024-10-08
00888118144539IPSKLS-Martin L.P.GXP2024-10-08
00888118144546IPSKLS-Martin L.P.GXP2024-10-08
00850391007245Montage Settable Bone PuttyABYRX, INC.GXP2023-11-16
00850391007252Montage Settable Bone PuttyABYRX, INC.GXP2023-11-16
08885013201307OsteoplugOSTEOPORE INTERNATIONAL PTE. LTD.GXP2023-08-02
08885013201314OsteoplugOSTEOPORE INTERNATIONAL PTE. LTD.GXP2023-08-02
00888118140050IPSKLS-Martin L.P.GXP2023-03-22
00888118140067IPSKLS-Martin L.P.GXP2023-03-22
00888118140074IPSKLS-Martin L.P.GXP2023-03-22
00888118140098IPSKLS-Martin L.P.GXP2023-03-22
00888118140142IPSKLS-Martin L.P.GXP2023-03-22
00888118140159IPSKLS-Martin L.P.GXP2023-03-22
00888118140173IPSKLS-Martin L.P.GXP2023-03-22
00888118140197IPSKLS-Martin L.P.GXP2023-03-22
00888118140227IPSKLS-Martin L.P.GXP2023-03-22
00888118140258IPSKLS-Martin L.P.GXP2023-03-22
00888118140319IPSKLS-Martin L.P.GXP2023-03-22
08885013200133OsteomeshOSTEOPORE INTERNATIONAL PTE. LTD.GXP2022-09-26
08885013201321OsteoplugOSTEOPORE INTERNATIONAL PTE. LTD.GXP2022-09-26
08885013201338OsteoplugOSTEOPORE INTERNATIONAL PTE. LTD.GXP2022-09-26
08885013200041OsteomeshOSTEOPORE INTERNATIONAL PTE. LTD.GXP2020-08-10
08885013200140OsteomeshOSTEOPORE INTERNATIONAL PTE. LTD.GXP2020-08-10
08885013200195OsteostripOSTEOPORE INTERNATIONAL PTE. LTD.GXP2020-08-10
08885013200409OsteostripOSTEOPORE INTERNATIONAL PTE. LTD.GXP2020-08-10