FDA.reportPublic FDA data

IPS

Primary DI
00888118141125
Brand
IPS
Company
KLS-Martin L.P.
Model
60-002-85-09-LP
Device description
CUTTING GUIDE, CRANIAL, TRANSFORM, EXTRA, LP
Published
2023-03-22
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
00888118141125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118141125008881181411258881181411250888118141125

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
00888118131782LEVEL ONE EXTREMITY26-066-60-092026-05-25
00888118131799LEVEL ONE EXTREMITY26-066-70-092026-05-25
00888118144928LEVEL ONE EXTREMITY26-950-40-072026-05-25
00888118145284PURE PECTUS24-070-60-092026-05-25
00888118145291PURE PECTUS24-070-62-092026-05-25
00888118150240PURE PECTUSCTM-241-100-012026-05-25
00888118150257PURE PECTUSCTM-241-101-012026-05-25
00888118150264PURE PECTUSCTM-241-200-012026-05-25
00888118150448IXOSCTM-263-100-012026-05-25
00888118150455IXOSCTM-263-101-012026-05-25
00888118150462IXOSCTM-263-202-012026-05-25
00888118150479IXOSCTM-263-202-022026-05-25
00888118150486IXOSCTM-263-202-032026-05-25
00888118150493IXOSCTM-263-202-042026-05-25
00888118150646IPS60-011-42-09-LP2026-05-25
00888118153029L1 STERNALCTM-242-302-012026-05-25
00888118153050IXOSCTM-263-203-012026-05-25
00888118153067IXOSCTM-263-203-022026-05-25
00888118153074IXOSCTM-263-203-032026-05-25
00888118153081IXOSCTM-263-203-042026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00888118144720IPSKLS-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
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
00888118128867IPSKLS-Martin L.P.PPT2020-09-21
00888118128898IPSKLS-Martin L.P.PPT2020-09-21
00888118122681IPSKLS-Martin L.P.PPT2019-09-20
00888118122698IPSKLS-Martin L.P.PPT2019-09-20
00888118122704IPSKLS-Martin L.P.PPT2019-09-20
00888118122711IPSKLS-Martin L.P.PPT2019-09-20
00888118122728IPSKLS-Martin L.P.PPT2019-09-20
00888118122735IPSKLS-Martin L.P.PPT2019-09-20
00888118099952IPSKLS-Martin L.P.PPT2018-10-24
00816847021425VSP Cranial3D SYSTEMS, INC.PPT2016-10-12
00816847021432VSP Cranial3D SYSTEMS, INC.PPT2016-10-12