FDA.reportPublic FDA data

IPS

Primary DI
00888118136077
Brand
IPS
Company
KLS-Martin L.P.
Model
60-002-46-09
Device description
IMPLANT, 2 QUADRANT, PREPROSTHETIC, TI-6AL-4V
Published
2022-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00888118136077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118136077008881181360778881181360770888118136077

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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118126528LEVEL ONE CMF, STERILE50-774-24-712020-04-22
00888118006530LEVEL ONE CMF01-405-08-092016-03-24
00888118034717LEVEL ONE CMF25-001-13-092016-03-24
00888118034731LEVEL ONE CMF25-002-13-092016-03-24
00888118034748LEVEL ONE CMF25-003-02-092016-03-24
00888118034816LEVEL ONE NEURO, STERILE25-003-10-712016-03-23
00888118034915LEVEL ONE NEURO25-003-21-092016-03-24
00888118035028LEVEL ONE NEURO25-005-12-092016-03-24
00888118035042LEVEL ONE CMF25-006-09-092016-03-24
00888118035721LEVEL ONE CMF25-010-03-092016-03-24
00888118035752LEVEL ONE CMF25-010-08-092016-03-24
00888118035882LEVEL ONE NEURO25-015-04-092016-03-24
00888118035912LEVEL ONE NEURO25-015-06-092016-03-24
00888118035943LEVEL ONE NEURO25-015-08-092016-03-24
00888118035974LEVEL ONE NEURO25-016-06-092016-03-24
00888118036018LEVEL ONE NEURO25-016-10-092016-03-24
00888118036049LEVEL ONE CMF25-017-04-092016-03-24
00888118036056LEVEL ONE CMF25-017-06-092016-03-24
00888118036063LEVEL ONE CMF25-017-08-092016-03-24
00888118036148LEVEL ONE CMF25-020-24-092016-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00888118148759IPSKLS-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
00888118141859IPSKLS-Martin L.P.ELE2023-08-24
00888118141866IPSKLS-Martin L.P.ELE2023-08-24
00888118141873IPSKLS-Martin L.P.ELE2023-08-24
00888118141880IPSKLS-Martin L.P.ELE2023-08-24
00888118128942IPSKLS-Martin L.P.ELE2022-10-04