FDA.reportPublic FDA data

IPS

Primary DI
00888118150646
Brand
IPS
Company
KLS-Martin L.P.
Model
60-011-42-09-LP
Device description
GUIDE, REFERENCE, PREPROSTHETIC, PA, LP
Published
2026-05-25
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
00888118150646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118150646008881181506468881181506460888118150646

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made organ/bone anatomy modelA model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier.

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
00888118108357DISTRACTION, INTERNAL, STERILE51-556-20-812018-09-26
00888118108364DISTRACTION, INTERNAL, STERILE51-557-20-812018-09-26
00888118147226LEVEL ONE EXTREMITY26-950-64-042026-07-21
00888118147233LEVEL ONE EXTREMITY26-950-65-042026-07-21
00888118147240LEVEL ONE EXTREMITY26-950-66-042026-07-21
00888118147257LEVEL ONE EXTREMITY26-950-67-042026-07-21
00888118147264LEVEL ONE EXTREMITY26-950-68-042026-07-21
00888118147271LEVEL ONE EXTREMITY26-950-69-042026-07-21
00888118147714LEVEL ONE EXTREMITY26-950-58-042026-07-21
00888118147721LEVEL ONE EXTREMITY26-950-59-042026-07-21
00888118147738LEVEL ONE EXTREMITY26-950-62-042026-07-21
00888118147745LEVEL ONE EXTREMITY26-950-63-042026-07-21
00888118154620LEVEL ONE CMF25-315-92-912026-07-21
00888118154637LEVEL ONE CMF50-743-06-092026-07-21
00888118154644LEVEL ONE, STERILE25-433-97-712026-07-21
00888118154651LEVEL ONE, STERILE25-438-97-712026-07-21
00888118154668LEVEL ONE, STERILE25-439-91-712026-07-21
00888118154675LEVEL ONE, STERILE25-486-97-712026-07-21
00888118154682LEVEL ONE, STERILE25-487-97-712026-07-21
00888118154699LEVEL ONE, STERILE50-817-15-712026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00888118136077IPSKLS-Martin L.P.ELE2022-10-04