FDA.reportPublic FDA data

IPS

Primary DI
00888118144720
Brand
IPS
Company
KLS-Martin L.P.
Model
60-002-89-09-PP
Device description
MARKING GUIDE, CRANIAL, TRANSFORM, EXTRA, ALT
Published
2024-10-08
Public version status
New
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
PPTCranial surgical planning and instrument guides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPTCranial Surgical Planning And Instrument GuidesNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118144720PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118144720008881181447208881181447200888118144720

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made organ/bone anatomy model/surgical guide kitA collection of custom-made devices intended to be used to assist anatomical visualization, surgical treatment planning, and intraoperative surgical procedures (e.g., orientation of implant components, guiding of surgical instruments). It consists of an anatomy model(s) of an organ/bone and an orthopaedic/craniomaxillofacial surgical guide(s) [e.g., for osteotomy, arthroplasty]; it is made of synthetic polymer materials and is manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device intended to be sterilized prior to use.

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
00888118150288LEVEL ONE CMF, STERILE50-280-00-712026-10-21
00888118150295LEVEL ONE CMF, STERILE50-280-03-712026-10-21
00888118150301LEVEL ONE CMF, STERILE50-280-05-712026-10-21
00888118150318LEVEL ONE CMF, STERILE50-280-07-712026-10-21
00888118150325LEVEL ONE CMF, STERILE50-280-09-712026-10-21
00888118150332LEVEL ONE CMF, STERILE50-280-11-712026-10-21
00888118150349LEVEL ONE CMF, STERILE50-282-00-712026-10-21
00888118150356LEVEL ONE CMF, STERILE50-282-03-712026-10-21
00888118150363LEVEL ONE CMF, STERILE50-282-05-712026-10-21
00888118150370LEVEL ONE CMF, STERILE50-282-07-712026-10-21
00888118150387LEVEL ONE CMF, STERILE50-282-09-712026-10-21
00888118150394LEVEL ONE CMF, STERILE50-282-11-712026-10-21
00888118150400LEVEL ONE CMF, STERILE50-302-09-712026-10-21
00888118150417LEVEL ONE CMF, STERILE50-302-11-712026-10-21
00888118154910LEVEL ONE CMF25-874-11-612026-10-21
00888118154927LEVEL ONE CMF25-874-11-912026-10-21
00888118154934LEVEL ONE CMF25-874-15-912026-10-21
00888118154941LEVEL ONE CMF25-874-15-612026-10-21
00888118154958LEVEL ONE CMF, STERILE25-874-11-712026-10-21
00888118154965LEVEL ONE CMF, STERILE25-874-15-712026-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05420060351297TRUMATCHMaterialise NVPPT2026-10-22
05420060351303TRUMATCHMaterialise NVPPT2026-10-22
05420060351310TRUMATCHMaterialise NVPPT2026-10-22
05420060351327TRUMATCHMaterialise NVPPT2026-10-22
05420060351341TRUMATCHMaterialise NVPPT2026-10-22
05420060351358TRUMATCHMaterialise NVPPT2026-10-22
05420060351365TRUMATCHMaterialise NVPPT2026-10-22
05420060351372TRUMATCHMaterialise NVPPT2026-10-22
05420060351389TRUMATCHMaterialise NVPPT2026-10-22
05420060351396TRUMATCHMaterialise NVPPT2026-10-22
05420060351402TRUMATCHMaterialise NVPPT2026-10-22
05420060350856TruMatch CMF Titanium 3D Printed GuidesMaterialise NVPPT2026-04-29
05420060351631TruMatch CMF Titanium 3D Printed GuidesMaterialise NVPPT2026-04-29
05420060351648TruMatch CMF Titanium 3D Printed GuidesMaterialise NVPPT2026-04-29
00888118144683IPSKLS-Martin L.P.PPT2024-10-08
00888118140999IPSKLS-Martin L.P.PPT2023-03-22
00888118141002IPSKLS-Martin L.P.PPT2023-03-22
00888118141019IPSKLS-Martin L.P.PPT2023-03-22
00888118141026IPSKLS-Martin L.P.PPT2023-03-22
00888118141071IPSKLS-Martin L.P.PPT2023-03-22
00888118141088IPSKLS-Martin L.P.PPT2023-03-22
00888118141125IPSKLS-Martin L.P.PPT2023-03-22
00888118141163IPSKLS-Martin L.P.PPT2023-03-22
00888118141408IPSKLS-Martin L.P.PPT2023-03-22
00888118136190IPSKLS-Martin L.P.PPT2022-11-25
00888118136718IPSKLS-Martin L.P.PPT2022-11-25
00888118136725IPSKLS-Martin L.P.PPT2022-11-25
00888118136732IPSKLS-Martin L.P.PPT2022-11-25
00888118129260IPSKLS-Martin L.P.PPT2020-12-22
00888118129307IPSKLS-Martin L.P.PPT2020-12-22