Home GUDID 00888118145260 LEVEL ONE CMF, STERILE
Primary DI 00888118145260
Brand LEVEL ONE CMF, STERILE
Company KLS-Martin L.P.
Model 25-096-08-74
Device description SCREW, MAXDRIVE, MMF, DRILL FREE, WIDE THD, 46* FLUTE, STAINLESS STEEL ASTM F138
Published 2024-12-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name DZL SCREW, FIXATION, INTRAOSSEOUS
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DZL Screw, Fixation, Intraosseous Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10888118145267 Primary GS1 0 00888118145260 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10888118145267 10888118145267 00888118145260 00888118145260 888118145260 0888118145260
GMDN Terms# Term, Definition table Term Definition Craniofacial bone screw, non-bioabsorbable A small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Regulatory Flags# DUNS number 826499238 Device count 4 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00888118108357 DISTRACTION, INTERNAL, STERILE 51-556-20-81 2018-09-26 00888118108364 DISTRACTION, INTERNAL, STERILE 51-557-20-81 2018-09-26 00888118147226 LEVEL ONE EXTREMITY 26-950-64-04 2026-07-21 00888118147233 LEVEL ONE EXTREMITY 26-950-65-04 2026-07-21 00888118147240 LEVEL ONE EXTREMITY 26-950-66-04 2026-07-21 00888118147257 LEVEL ONE EXTREMITY 26-950-67-04 2026-07-21 00888118147264 LEVEL ONE EXTREMITY 26-950-68-04 2026-07-21 00888118147271 LEVEL ONE EXTREMITY 26-950-69-04 2026-07-21 00888118147714 LEVEL ONE EXTREMITY 26-950-58-04 2026-07-21 00888118147721 LEVEL ONE EXTREMITY 26-950-59-04 2026-07-21 00888118147738 LEVEL ONE EXTREMITY 26-950-62-04 2026-07-21 00888118147745 LEVEL ONE EXTREMITY 26-950-63-04 2026-07-21 00888118154620 LEVEL ONE CMF 25-315-92-91 2026-07-21 00888118154637 LEVEL ONE CMF 50-743-06-09 2026-07-21 00888118154644 LEVEL ONE, STERILE 25-433-97-71 2026-07-21 00888118154651 LEVEL ONE, STERILE 25-438-97-71 2026-07-21 00888118154668 LEVEL ONE, STERILE 25-439-91-71 2026-07-21 00888118154675 LEVEL ONE, STERILE 25-486-97-71 2026-07-21 00888118154682 LEVEL ONE, STERILE 25-487-97-71 2026-07-21 00888118154699 LEVEL ONE, STERILE 50-817-15-71 2026-07-21
Other Devices Sharing Product Codes# 
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