FDA.reportPublic FDA data

IPS

Primary DI
00888118141613
Brand
IPS
Company
KLS-Martin L.P.
Model
60-500-19-09-LP
Device description
SPLINT, INTERMEDIATE, FREEPRINT ORTHO, LP
Published
2023-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZJDRIVER, WIRE, AND BONE DRILL, MANUAL
JEYPLATE, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2
JEYPlate, BoneDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118141613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118141613008881181416138881181416130888118141613

GMDN Terms#

Term, Definition table
TermDefinition
Dental occlusal splint, custom-madeA rigid or flexible custom-made appliance that overlays the occlusal surfaces of the teeth. It is used to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). This is a reusable device.

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
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
07613327711578NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
07613327711585NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
07613327711592NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
07613327711608NAStryker Leibinger GmbH & Co. KGJEY2026-09-24
04046826486228MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
04046826531478MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
04046826531485MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
04046826561741MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-29
04046826531454MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJEY2026-07-28
00888118154620LEVEL ONE CMFKLS-Martin L.P.JEY2026-07-21
00888118154637LEVEL ONE CMFKLS-Martin L.P.JEY2026-07-21
07613327694482DELTAStryker Leibinger GmbH & Co. KGJEY2026-07-21
07613327694499DELTAStryker Leibinger GmbH & Co. KGJEY2026-07-21
00860015267801EmbedMed3D LIFEPRINTS UK LTDDZJ2026-03-30
00860012759446TECHFITTechfit Digital Surgery, Inc.DZJ2025-03-17
00860012759453TECHFITTechfit Digital Surgery, Inc.DZJ2025-03-17
00860012759460TECHFITTechfit Digital Surgery, Inc.DZJ2025-03-17
05420060380747TRUMATCHMaterialise NVDZJ2025-02-28
00860012759408TECHFITTechfit Digital Surgery, Inc.DZJ2024-09-13
00860012759415TECHFITTechfit Digital Surgery, Inc.DZJ2024-09-13
00860012759422TECHFITTechfit Digital Surgery, Inc.DZJ2024-09-13
00860011469285TECHFITTechfit Digital Surgery, Inc.DZJ2024-08-28
00860011469261TECHFITTechfit Digital Surgery, Inc.DZJ2024-02-22
00860011469278TECHFITTechfit Digital Surgery, Inc.DZJ2024-02-22
00860011469216TECHFITTechfit Digital Surgery, Inc.DZJ2024-02-06
00860011469223TECHFITTechfit Digital Surgery, Inc.DZJ2024-02-06
00860011469230TECHFITTechfit Digital Surgery, Inc.DZJ2024-02-06
07392532239045Symbios®Dentsply Implants Manufacturing GmbHJEY2024-01-30
07392532239052Symbios®Dentsply Implants Manufacturing GmbHJEY2024-01-30
07392532239038Symbios®Dentsply Implants Manufacturing GmbHJEY2024-01-29