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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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DETAX GmbH
03000
In Commercial Distribution

  • EDET030001 ()


  • Denture reliner, elastic, long-term
Bioactive mineral Root Canal Sealer
SEPTODONT SAS SPECIALITES SEPTODONT
01E0510
In Commercial Distribution

  • 03701398102556 ()
01E0510

  • Hygroscopic dental cement
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
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