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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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No Description
DETAX GmbH
03001
In Commercial Distribution

  • EDET030011 ()


  • Denture reliner, elastic, long-term
No Description
DETAX GmbH
03000
In Commercial Distribution

  • EDET030001 ()


  • Denture reliner, elastic, long-term
The product is suitable for root canal therapy for root canal cleaning and shaping. Can be reused.
Meta Biomed Co., Ltd.
5083
In Commercial Distribution

  • 08806387850830 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
The product is suitable for root canal therapy for root canal cleaning and shaping. Can be reused.
Meta Biomed Co., Ltd.
5080
In Commercial Distribution

  • 08806387850809 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
The product is suitable for root canal therapy for root canal cleaning and shaping. Can be reused.
Meta Biomed Co., Ltd.
5077
In Commercial Distribution

  • 08806387850779 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
The product is suitable for root canal therapy for root canal cleaning and shaping. Can be reused.
Meta Biomed Co., Ltd.
5074
In Commercial Distribution

  • 08806387850748 ()


  • Rotary/reciprocating endodontic file/rasp, reusable
Bioactive mineral Root Canal Sealer
SEPTODONT SAS SPECIALITES SEPTODONT
01E0510
In Commercial Distribution

  • 03701398102556 ()
01E0510

  • Hygroscopic dental cement
Instrument Adaptor 28160 G instrument Rosa One 3.1 (brain application) Ventricular endoscopy instrument adaptor to accomodate ventricular endoscopy instrument holder. Not for drilling"
MEDTECH
174094-01
In Commercial Distribution

  • 03760244033338 ()
ROSAS00326

  • Multi-purpose stereotactic surgery system
Instrument Adaptor 28160 G instrument Rosa 3.0 instrument ROSA3.1 Ventricular endoscopy instrument adaptor to accomodate ventricular endoscopy instrument holder. Not for drilling
MEDTECH
ROSA3-116A
In Commercial Distribution

  • 03760244031242 ()
ROSAS00326

  • Multi-purpose stereotactic surgery system
  • Neurological stereotactic surgery system
Instrument Adaptor 28160 G instrument Rosa One 3.1 (brain application) Ventricular endoscopy instrument adaptor to accomodate ventricular endoscopy instrument holder. Not for drilling"
MEDTECH
174094-00
In Commercial Distribution

  • 03760244031099 ()
ROSAS00326

  • Multi-purpose stereotactic surgery system
Thawing and warming device for HPC, blood products, IV solution
Barkey GmbH & Co. KG
US-C&G 2.Gen
In Commercial Distribution

  • 04059201002135 ()
00010340

  • Cryopreserved blood/tissue thawing unit
Thawing and warming device for frozen plasma (FFP, PF24 ,AHF), Whole Blood, RBC and IV solution
Barkey GmbH & Co. KG
US-C&G
In Commercial Distribution

  • 04059201001817 ()
00003475

  • Cryopreserved blood/tissue thawing unit
AGILITY® CERAMIC ROTH .022 LR4 HK -17°T 0°A BRACKETS
G & H Wire Company, Inc.
125-L4-2RK-V
In Commercial Distribution

  • 10190886015049 ()
  • 00190886015042 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC ROTH .018 LR3 HK -11°T +5°A 2°R BRACKETS
G & H Wire Company, Inc.
125-L3-8RK-V
In Commercial Distribution

  • 10190886015025 ()
  • 00190886015028 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC ROTH .022 LR3 HK -11°T +5°A 2°R BRACKETS
G & H Wire Company, Inc.
125-L3-2RK-V
In Commercial Distribution

  • 10190886015001 ()
  • 00190886015004 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC ROTH BRACKETS .018 L1/2 0°T 0°A
G & H Wire Company, Inc.
125-L1-8U-V
In Commercial Distribution

  • 10190886014981 ()
  • 00190886014984 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC BRACKET SYSTEM MBT PRESCRIPTION .022 FULL CASE HOOKS ON 3,4,5 (20 BRACKETS)
G & H Wire Company, Inc.
126K-345-22-01
In Commercial Distribution

  • 10190886015605 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC BRACKET SYSTEM MBT PRESCRIPTION .018 FULL CASE HOOKS ON 3,4,5 (20 BRACKETS)
G & H Wire Company, Inc.
126K-345-18-01
In Commercial Distribution

  • 10190886015599 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC MBT .018 UR4/5 HK -7°T 0°A BRACKETS
G & H Wire Company, Inc.
126-U4-8RK-V
In Commercial Distribution

  • 10190886015582 ()
  • 00190886015585 ()


  • Orthodontic bracket, ceramic
AGILITY® CERAMIC MBT .018 UL4/5 HK -7°T 0°A BRACKETS
G & H Wire Company, Inc.
126-U4-8LK-V
In Commercial Distribution

  • 10190886015575 ()
  • 00190886015578 ()


  • Orthodontic bracket, ceramic
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