Home GUDID 00845694044998 OsteoMed
Primary DI 00845694044998
Brand OsteoMed
Company OSTEOMED LLC
Model 218-3060-SP
Catalog number 218-3060-SP
Device description SmartFlex Spring - Small - 6N
Published 2015-04-07
Public version status Update
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 PBJ Cranial Distraction System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PBJ Cranial Distraction System Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00845694044998 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00845694044998 00845694044998 845694044998 0845694044998
GMDN Terms# Term, Definition table Term Definition Cranioplasty plate, alterable An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material (e.g., tantalum) that can be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Regulatory Flags# DUNS number 606417780 Device count 1 DM exempt true 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00888118149367 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2025-09-24 00888118136589 DISTRACTION, INTERNAL KLS-Martin L.P. PBJ 2023-12-25 00888118136596 DISTRACTION, INTERNAL KLS-Martin L.P. PBJ 2023-12-25 00888118136626 DISTRACTION, INTERNAL KLS-Martin L.P. PBJ 2023-12-25 00888118136633 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2023-12-25 00888118136640 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2023-12-25 00888118136657 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2023-12-25 H98004315852010 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315784010 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315788010 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315792010 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315806010 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315824050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315832050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315786050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315788050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315790050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315804050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315846050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315850050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315808050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 H98004315810050 NA SYNTHES (U.S.A.) LP PBJ 2019-12-12 00842528123300 OsteoMed OSTEOMED LLC PBJ 2019-11-08 00842528123317 OsteoMed OSTEOMED LLC PBJ 2019-11-08 00888118114310 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2018-01-12 00888118114464 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2018-01-12 00888118114471 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2018-01-12 00888118114488 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2018-01-12 00888118114495 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2018-01-12 00888118114501 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. PBJ 2018-01-12