Home GUDID 34546540055447 ACM BioPrep
Primary DI 34546540055447
Brand ACM BioPrep
Company STRYKER CORPORATION
Model 0306708000
Catalog number 0306708000
Device description Total Joint Kit
Published 2015-09-24
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 LZN CEMENT OBTURATOR
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LZN Cement Obturator General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 34546540055447 Package GS1 6 In Commercial Distribution 04546540055446 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 34546540055447 34546540055447 04546540055446 04546540055446 4546540055446
GMDN Terms# Term, Definition table Term Definition Manual orthopaedic cement mixer, reusable A hand-operated manual device designed to mix polymethylmethacrylate (PMMA) powder with methylmethacrylate monomer in order to produce polymerizing bone cement. It typically includes a single-use inner mixing bowl where the cement is mixed, an outer housing with a handcrank and driving gears connected to a disposable mixing blade(s), and a lid. The device is intended to be connected to, or placed under, a fume extraction device to prevent fumes from polluting the working environment; it is typically operated outside of the sterile surgical field. This is a reusable device.
Regulatory Flags# DUNS number 196548481 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true 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 03760177046542 CLEARCUT TEKNIMED LZN 2020-11-25 03760177046573 CLEARCUT TEKNIMED LZN 2020-11-25 03760177046603 CLEARCUT TEKNIMED LZN 2020-11-25 03760177046634 CLEARCUT TEKNIMED LZN 2020-11-25 03760177046665 CLEARCUT TEKNIMED LZN 2020-11-25 03760177046696 CLEARCUT TEKNIMED LZN 2020-11-25 03760177046535 CLEARCUT TEKNIMED LZN 2020-09-24 00889024510326 NA Zimmer, Inc. LZN 2018-09-14 00889024510333 NA Zimmer, Inc. LZN 2018-09-14 00889024510340 NA Zimmer, Inc. LZN 2018-09-14 00889024510357 NA Zimmer, Inc. LZN 2018-09-14 00889024510364 NA Zimmer, Inc. LZN 2018-09-14 00889024510371 NA Zimmer, Inc. LZN 2018-09-14 00888912023443 DJO SURGICAL Encore Medical, L.P. LZN 2017-05-04 00888912023450 DJO SURGICAL Encore Medical, L.P. LZN 2017-05-04 00888912023467 DJO SURGICAL Encore Medical, L.P. LZN 2017-05-04 00888912023474 DJO SURGICAL Encore Medical, L.P. LZN 2017-05-04 00888912023481 DJO SURGICAL Encore Medical, L.P. LZN 2017-05-04 00888912073806 DJO SURGICAL Encore Medical, L.P. LZN 2017-05-04 00889024376724 NA Zimmer, Inc. LZN 2016-08-31 00889024376748 NA Zimmer, Inc. LZN 2016-08-31 00889024376755 NA Zimmer, Inc. LZN 2016-08-31 00889024380189 NA Zimmer, Inc. LZN 2016-08-31 00889024432918 NA Zimmer, Inc. LZN 2016-07-15 00889024432970 NA Zimmer, Inc. LZN 2016-05-24 00889024432987 NA Zimmer, Inc. LZN 2016-05-24 00889024432994 NA Zimmer, Inc. LZN 2016-05-24 00889024433007 NA Zimmer, Inc. LZN 2016-05-24 00889024433014 NA Zimmer, Inc. LZN 2016-05-24 00889024433021 NA Zimmer, Inc. LZN 2016-05-24