FDA.reportPublic FDA data

IPS

Primary DI
00888118148759
Brand
IPS
Company
KLS-Martin L.P.
Model
60-011-20-09-LP
Device description
IMPLANT, 2 QUADRANT, PREPROSTHETIC, MUA, W/OUT FINAL, LP, TI-6AL-4V
Published
2025-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELEIMPLANT, SUBPERIOSTEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELEImplant, SubperiostealDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118148759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118148759008881181487598881181487590888118148759

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made cranial bone prosthesisAn 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
00888118086037SILICONE MAT55-348-01-012020-06-19
00888118125729TRAY55-804-25-012020-06-19
00888118003119CARRIER00-105-92-072018-09-26
00888118006974CURETTE01-500-01-072018-09-26
00888118006981CURETTE01-500-02-072018-09-26
00888118006998CURETTE01-500-03-072018-09-26
00888118008626CALIPER04-407-20-072018-09-26
00888118009012SCOPE HOLDER ARM07-001-42-072016-09-20
00888118009029SCOPE HOLDER CLAMP07-001-43-072016-09-20
00888118009050SCOPE HOLDER ARM07-001-49-072016-09-20
00888118022950PHLEBEXTRACTOR16-249-02-072018-09-26
00888118022967PHLEBEXTRACTOR16-249-03-072018-09-26
00888118022981STRIPPER16-251-02-012018-09-26
00888118022998STRIPPER16-251-03-012018-09-26
00888118023001STRIPPER16-251-04-012018-09-26
00888118023018STRIPPER16-251-06-012018-09-26
00888118023025STRIPPER16-251-07-012018-09-26
00888118023032STRIPPER16-251-08-012018-09-26
00888118023049STRIPPER16-251-10-012018-09-26
00888118023056STRIPPER16-251-14-012018-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888118145819IPSKLS-Martin L.P.ELE2026-10-01
00888118145826IPSKLS-Martin L.P.ELE2026-10-01
00888118145833IPSKLS-Martin L.P.ELE2026-10-01
00888118145840IPSKLS-Martin L.P.ELE2026-10-01
00888118145857IPSKLS-Martin L.P.ELE2026-10-01
00888118145864IPSKLS-Martin L.P.ELE2026-10-01
00888118150646IPSKLS-Martin L.P.ELE2026-05-25
00888118140968IPSKLS-Martin L.P.ELE2025-11-26
00888118140975IPSKLS-Martin L.P.ELE2025-11-26
00888118140982IPSKLS-Martin L.P.ELE2025-11-26
00888118141804IPSKLS-Martin L.P.ELE2025-11-26
00888118141811IPSKLS-Martin L.P.ELE2025-11-26
00888118141828IPSKLS-Martin L.P.ELE2025-11-26
00888118148742IPSKLS-Martin L.P.ELE2025-11-26
00888118148766IPSKLS-Martin L.P.ELE2025-11-26
00888118148773IPSKLS-Martin L.P.ELE2025-11-26
00888118148780IPSKLS-Martin L.P.ELE2025-11-26
00888118148797IPSKLS-Martin L.P.ELE2025-11-26
00888118148803IPSKLS-Martin L.P.ELE2025-11-26
00888118148810IPSKLS-Martin L.P.ELE2025-11-26
00888118148827IPSKLS-Martin L.P.ELE2025-11-26
00888118148834IPSKLS-Martin L.P.ELE2025-11-26
00888118145024IPSKLS-Martin L.P.ELE2024-11-25
00888118145031IPSKLS-Martin L.P.ELE2024-11-25
00888118145048IPSKLS-Martin L.P.ELE2024-11-25
00888118145055IPSKLS-Martin L.P.ELE2024-11-25
00888118145062IPSKLS-Martin L.P.ELE2024-11-25
00888118145079IPSKLS-Martin L.P.ELE2024-11-25
00888118141835IPSKLS-Martin L.P.ELE2023-08-24
00888118141842IPSKLS-Martin L.P.ELE2023-08-24