Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9524
Not in Commercial Distribution

  • 08806387895244 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9523
Not in Commercial Distribution

  • 08806387895237 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9522
Not in Commercial Distribution

  • 08806387895220 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9521
Not in Commercial Distribution

  • 08806387895213 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9520
Not in Commercial Distribution

  • 08806387895206 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9519
In Commercial Distribution

  • 08806387895190 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9518
Not in Commercial Distribution

  • 08806387895183 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9517
Not in Commercial Distribution

  • 08806387895176 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9516
Not in Commercial Distribution

  • 08806387895169 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9515
Not in Commercial Distribution

  • 08806387895152 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9514
Not in Commercial Distribution

  • 08806387895145 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9513
Not in Commercial Distribution

  • 08806387895138 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9512
Not in Commercial Distribution

  • 08806387895121 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9511
Not in Commercial Distribution

  • 08806387895114 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9510
Not in Commercial Distribution

  • 08806387895107 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9509
Not in Commercial Distribution

  • 08806387895091 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9508
Not in Commercial Distribution

  • 08806387895084 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9507
Not in Commercial Distribution

  • 08806387895077 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9506
Not in Commercial Distribution

  • 08806387895060 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9505
Not in Commercial Distribution

  • 08806387895053 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9504
Not in Commercial Distribution

  • 08806387895046 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9503
Not in Commercial Distribution

  • 08806387895039 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9502
Not in Commercial Distribution

  • 08806387895022 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9501
Not in Commercial Distribution

  • 08806387895015 ()


  • Bone matrix implant, synthetic, non-antimicrobial
BoneMedik is coralline hydroxyapatite bone void fillers. BoneMedik is osteoconductive porous implant materials similar in structure to human cancellous bone. The material is trabecular hydroxyapatite.
Meta Biomed Co., Ltd.
9500
Not in Commercial Distribution

  • 08806387895008 ()


  • Bone matrix implant, synthetic, non-antimicrobial
Ultra Band-Lok® is intended for use as an orthodontic band cement and for occlusal buildups. This product is Natural shade. This product is Non-Fluoride
RELIANCE ORTHODONTIC PRODUCTS INC
NFUBLPP
In Commercial Distribution

  • D798NFUBLPP0 ()
NFUBLPP

  • Dental composite resin
Ultra Band-Lok® is intended for use as an orthodontic band cement and for occlusal buildups. This product is blue shade. This product is Non-Fluoride
RELIANCE ORTHODONTIC PRODUCTS INC
NFUBLBPP
In Commercial Distribution

  • D798NFUBLBPP0 ()
NFUBLBPP

  • Dental composite resin
TLE1 is a is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB23180 ()
BSB 2318

  • Transducin-like enhancer protein IVD, antibody
The basis is part of the container which product number is 239000ND and that is used for transport and sterilization of instruments and non-steril implants..
NEWDEAL
239001ND
In Commercial Distribution

  • M248239001ND1 ()
  • 10381780042426 ()


  • Device sterilization/disinfection container, reusable
The screw rack is part of the container which product number is 188201ND and that is used for transport and sterilization of non sterile implants.
NEWDEAL
188215ND
Not in Commercial Distribution

  • M248188215ND1 ()
  • 10381780042365 ()


  • Device sterilization/disinfection container, reusable
BEAR™ is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use. BEAR™ is a smart microcurrent facial toning device.
Foreo AB
FUCHSIA
In Commercial Distribution

  • 07350092139502 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
BEAR™ is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use. BEAR™ is a smart microcurrent facial toning device.
Foreo AB
MINT
In Commercial Distribution

  • 07350120790118 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
External quality controls to monitor the performance of in vitro laboratory nucleic acid detection and quantification of BCR-ABL1 fusion gene using molecular test systems.
Mmqci
v.00
In Commercial Distribution

  • 00852720008367 ()
C240

  • Philadelphia chromosome/BCR-ABL transcript IVD, control
Reference material to monitor the performance of the in vitro quantitative detection of BCR-ABL1 and ABL1 mRNA transcripts for Xpert BCR-ABL Ultra assay on the Cepheid GeneXpert system.
Mmqci
v.00
In Commercial Distribution

  • 00852720008183 ()
C207

  • Philadelphia chromosome/BCR-ABL transcript IVD, control
IntelliSpace Console Critical Care B.0
Philips Medical Systems Hsg
IntelliSpace Console Critical Care
Not in Commercial Distribution

  • 00884838085305 ()
867065

  • Medical equipment clinical data interfacing software
The device is an Ear and forehead thermometer, which is intended to measure human body temperature.
Shenzhen Dongdixin Technology Co.,Ltd.
DSO364
In Commercial Distribution

  • 06926408700011 ()
  • 16926408700018 ()


  • Infrared patient thermometer, skin
  • Infrared patient thermometer, ear
The device is an ear and forehead thermometer, which is intended to measure human body temperature.
Shenzhen Brav Electronic Technologies Co., Ltd.
IT-121S
In Commercial Distribution

  • 06926347917419 ()


  • Infrared patient thermometer, ear
The device is an ear and forehead thermometer,which is intended to measure human body temperature.
Shenzhen Brav Electronic Technologies Co., Ltd.
EFT-165
In Commercial Distribution

  • 06926347911653 ()


  • Infrared patient thermometer, ear
The device is an ear and forehead thermometer,which is intended to measure human body temperature.
Shenzhen Brav Electronic Technologies Co., Ltd.
EFT-166
In Commercial Distribution

  • 06926347901661 ()


  • Infrared patient thermometer, ear
The device is an ear and forehead thermometer, which is intended to measure human body temperature.
Shenzhen Brav Electronic Technologies Co., Ltd.
EFT-161
In Commercial Distribution

  • 06926347901616 ()


  • Infrared patient thermometer, ear
Balloon Inflation Device Maximum pressure is 15atm , the length is 60mm, 5 pcs in the box
Micro-Tech (Nanjing) Co., Ltd.
BID-15-60-01
In Commercial Distribution

  • 16932503525012 ()
  • 06932503525015 ()
  • 26932503525019 ()
  • 36932503525016 ()

  • Pressure: 15 Atmosphere
  • Total Volume: 60 Milliliter


  • Catheter/overtube balloon inflator, single-use
Nexcomp flow kit is a light-cured composite and variable shade. The material is radiopaque flowable resin.
Meta Biomed Co., Ltd.
9244
In Commercial Distribution

  • 08806387892441 ()


  • Dental composite resin
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Syringe. Italian..
SCIENTIFIC PHARMACEUTICALS, INC.
ID 65-024 I
In Commercial Distribution

  • D801ID65024I1 ()
65-024

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix. Primer. Italian.
SCIENTIFIC PHARMACEUTICALS, INC.
ID 65-021 I
In Commercial Distribution

  • D801ID65021I1 ()
65-021

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Spanish.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-02 S
In Commercial Distribution

  • D801SP6502S1 ()
65-02

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Non-Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-021 N
In Commercial Distribution

  • D801SP65021N1 ()
65-021

  • Dentine adhesive
Cure-On Touch is a direct bonding material and is a light-cured adhesive No Mix Jar. Boxed.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 65-021 B
In Commercial Distribution

  • D801SP65021B1 ()
65-021

  • Dentine adhesive
The handle is proposed as accessory for the carbon offset reamer handles.This is a reusable device.
MPS Micro Precision Systems AG
T18180
In Commercial Distribution

  • 07640187914092 ()
T18180

  • Surgical power tool adaptor
Calcitonin is a rabbit monoclonal antibody that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB64110 ()
BSB 6411

  • Calcitonin IVD, antibody
Calcitonin is a rabbit monoclonal antibody that is filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 7 ml
In Commercial Distribution

  • B502BSB64090 ()
BSB 6409

  • Calcitonin IVD, antibody
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