FDA.report

IPS

Primary DI
00888118154231
Brand
IPS
Company
KLS-Martin L.P.
Model
60-011-41-09-LP
Device description
GUIDE, OCCLUSALOCK, LP
Published
2026-05-25
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
LLZSystem, image processing, radiological

Product Code Classifications

CodeDeviceSpecialtyClass
DZJDriver, Wire, And Bone Drill, ManualDental2
LLZSystem, Image Processing, RadiologicalRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888118154231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118154231008881181542318881181542310888118154231

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

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00888118153074IXOSCTM-263-203-032026-05-25
00888118153081IXOSCTM-263-203-042026-05-25

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