FDA.report

IPS

Primary DI
00888118129239
Brand
IPS
Company
KLS-Martin L.P.
Model
60-002-82-09
Device description
CUTTING GUIDE, W/PLANNING, TRANSFORM
Published
2020-12-22
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

Contact Domains

Product Codes

CodeName
DZJDRIVER, WIRE, AND BONE DRILL, MANUAL

Product Code Classifications

CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888118129239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118129239008881181292398881181292390888118129239

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
00888118149572IPSKLS-Martin L.P.DZJ2026-02-23
00888118149589IPSKLS-Martin L.P.DZJ2026-02-23
00888118149626IPSKLS-Martin L.P.DZJ2026-02-23
00888118149336IPSKLS-Martin L.P.DZJ2025-11-26
05420060380839TRUMATCHMaterialise NVDZJ2025-09-11
05420060380846TRUMATCHMaterialise NVDZJ2025-09-11
05420060380853TRUMATCHMaterialise NVDZJ2025-09-11
05420060380860TRUMATCHMaterialise NVDZJ2025-09-11
05420060380877TRUMATCHMaterialise NVDZJ2025-09-11
05420060380884TRUMATCHMaterialise NVDZJ2025-09-11
05420060380891TRUMATCHMaterialise NVDZJ2025-09-11
05420060380907TRUMATCHMaterialise NVDZJ2025-09-11
00840124519633PolyLockFUSION ORTHOPEDICS, LLCDZJ2025-05-15
00840124519640PolyLockFUSION ORTHOPEDICS, LLCDZJ2025-05-15
00840124519893PolyLock MidfootFUSION ORTHOPEDICS, LLCDZJ2025-05-15
00840124519909PolyLock MidfootFUSION ORTHOPEDICS, LLCDZJ2025-05-15
00840124519916PolyLock MidfootFUSION ORTHOPEDICS, LLCDZJ2025-05-15
00888118145086IPSKLS-Martin L.P.DZJ2025-04-22
00888118145093IPSKLS-Martin L.P.DZJ2025-04-22
00888118145543IPSKLS-Martin L.P.DZJ2025-04-22
00888118145550IPSKLS-Martin L.P.DZJ2025-04-22
00888118145567IPSKLS-Martin L.P.DZJ2025-04-22
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
05420060380754TRUMATCHMaterialise NVDZJ2025-02-28
05420060380761TRUMATCHMaterialise NVDZJ2025-02-28
00840124514416FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCDZJ2024-12-04
00810007632889AccuPlan System MedcadDZJ2024-10-18