FDA.report

IPS

Primary DI
00888118141019
Brand
IPS
Company
KLS-Martin L.P.
Model
60-002-58-09-LP
Device description
MARKING GUIDE, CRANIAL, SECONDARY, 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
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
PPTCranial surgical planning and instrument guides

Product Code Classifications

CodeDeviceSpecialtyClass
PPTCranial Surgical Planning And Instrument GuidesNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888118141019PrimaryGS10

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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 DIBrandModelCatalogPublished
00888118143266PURE PECTUS24-070-40-092026-03-23
00888118143273PURE PECTUS24-070-42-092026-03-23
00888118143280PURE PECTUS24-070-44-092026-03-23
00888118143297PURE PECTUS24-070-46-092026-03-23
00888118143303PURE PECTUS24-070-48-092026-03-23
00888118143310PURE PECTUS24-070-50-092026-03-23
00888118143327PURE PECTUS24-071-40-092026-03-23
00888118143334PURE PECTUS24-071-42-092026-03-23
00888118143341PURE PECTUS24-071-44-092026-03-23
00888118143358PURE PECTUS24-071-46-092026-03-23
00888118143365PURE PECTUS24-071-48-092026-03-23
00888118143372PURE PECTUS24-071-50-092026-03-23
00888118145321PURE PECTUS24-070-50-892026-03-23
00888118145338PURE PECTUS24-071-50-892026-03-23
00888118149671LEVEL ONE CMF, STERILE25-882-06-712026-03-23
00888118149701LEVEL ONE CMF, STERILE25-883-17-712026-03-23
00888118149718LEVEL ONE CMF, STERILE25-883-19-712026-03-23
00888118149725LEVEL ONE CMF, STERILE25-887-17-712026-03-23
00888118149732LEVEL ONE CMF, STERILE25-887-19-712026-03-23
00888118149749LEVEL ONE CMF, STERILE25-889-09-712026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
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
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
00816847021449VSP Cranial3D SYSTEMS, INC.PPT2016-10-12
00816847021456VSP System, VSP Cranial3D SYSTEMS, INC.PPT2016-10-12