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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Turbine
MK-Dent GmbH
ECO LINE
In Commercial Distribution

HE21K

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
ECO LINE
In Commercial Distribution

  • E490HE20KL1 ()
HE20KL

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
ECO LINE
In Commercial Distribution

  • E490HE20K1 ()
HE20K

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
ECO LINE
In Commercial Distribution

HE18

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
ECO LINE
In Commercial Distribution

  • E490HE17B1 ()
HE17B

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
ECO LINE
In Commercial Distribution

HE17

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
ECO LINE
In Commercial Distribution

HE16L

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
ECO LINE
In Commercial Distribution

HE15L

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
ECO LINE
In Commercial Distribution

HE14

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
ECO LINE
In Commercial Distribution

HE12

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
ECO LINE
In Commercial Distribution

HE11

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
PRIME LINE
In Commercial Distribution

  • E490HC8021K1 ()
HC8021K

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
CLASSIC LINE
In Commercial Distribution

HC22KL

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
CLASSIC LINE
In Commercial Distribution

HC22K

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
CLASSIC LINE
In Commercial Distribution

HC21KL

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
CLASSIC LINE
In Commercial Distribution

HC21K

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
CLASSIC LINE
In Commercial Distribution

HC20KL

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
CLASSIC LINE
In Commercial Distribution

HC20K

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
BASIC LINE
In Commercial Distribution

HB23KL

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
BASIC LINE
In Commercial Distribution

HB23K

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
BASIC LINE
In Commercial Distribution

HB21KL

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
BASIC LINE
In Commercial Distribution

HB21K

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
BASIC LINE
In Commercial Distribution

HB16L

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
BASIC LINE
In Commercial Distribution

HB15L

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
BASIC LINE
In Commercial Distribution

HB14

  • Dental power tool handpiece motorless component
Turbine
MK-Dent GmbH
BASIC LINE
In Commercial Distribution

HB12

  • Dental power tool handpiece motorless component
No Description
LIVANOVA USA, INC.
Drain Line
In Commercial Distribution

  • 10803622132152 ()
  • 00803622132155 ()


  • Autotransfusion system blood component processing set
No Description
MASIMO CORPORATION
1853
In Commercial Distribution

  • 00843997001380 ()


  • Electrical-only medical device connection cable, reusable
No Description
MASIMO CORPORATION
1810
In Commercial Distribution

  • 00843997001359 ()


  • Electrical-only medical device connection cable, reusable
Bite Block, O2-CO2 monitoring and oxygen delivery, with strap
KEY SURGICAL, INC.
EN-315
Not in Commercial Distribution

  • 00849771043843 ()
  • 00849771037200 ()
EN315

  • Endoscopic bite block, oxygenating
No Description
BIOTRONIK SE & Co. KG
Smart 3G
In Commercial Distribution

  • 04035479139360 ()
401831

  • Patient monitoring modem
No Description
Merit Medical Systems, Inc.
10884450122782
In Commercial Distribution

  • 20884450122789 ()
  • 10884450122782 ()
  • 00884450122785 ()

  • Blade Length-110 mm
TIO60-110

  • Endoscopic bite block, oxygenating
No Description
Merit Medical Systems, Inc.
10884450122775
In Commercial Distribution

  • 20884450122772 ()
  • 10884450122775 ()
  • 00884450122778 ()

  • Blade Length-100 mm
TIO60-100

  • Endoscopic bite block, oxygenating
No Description
Merit Medical Systems, Inc.
10884450122768
In Commercial Distribution

  • 20884450122765 ()
  • 10884450122768 ()
  • 00884450122761 ()

  • Blade Length-90 mm
TIO60-90

  • Endoscopic bite block, oxygenating
LATITUDE ® Communicator
BOSTON SCIENTIFIC CORPORATION
6482
In Commercial Distribution

  • 00802526580802 ()


  • Patient monitoring modem
LATITUDE ® Communicator with Wand
BOSTON SCIENTIFIC CORPORATION
6481
In Commercial Distribution

  • 00802526580727 ()


  • Patient monitoring modem
Biotem IR COM OCTA ABUTMENT 6.0 mm (D) X 2.9 (Octa) x 5.5 mm (H)
Biotem Co., ltd
SAITB605EW
In Commercial Distribution

  • 08800036204142 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 6.0 mm (D) X 2.9 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAITB604EW
In Commercial Distribution

  • 08800036204135 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAITB40437
In Commercial Distribution

  • 08800036204128 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAIT40437
In Commercial Distribution

  • 08800036204098 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAIT40434
In Commercial Distribution

  • 08800036204074 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 6.0 mm (D) X 2.9 (Octa) x 7.0 mm (H)
Biotem Co., ltd
SAITB607EW
In Commercial Distribution

  • 08800036204159 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 5.5 mm (H)
Biotem Co., ltd
SAITB40435
In Commercial Distribution

  • 08800036204111 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 2.9 (Octa) x 4.0 mm (H)
Biotem Co., ltd
SAITB40434
In Commercial Distribution

  • 08800036204104 ()


  • Dental implant system
Biotem IR COM OCTA ABUTMENT 4.8 mm (D) X 3.1 (Octa) x 5.5 mm (H)
Biotem Co., ltd
SAIT40435
In Commercial Distribution

  • 08800036204081 ()


  • Dental implant system
50` Neonatal Circuit, Temp port, Prox line, Drop line, Neo
WESTMED, INC.
N6205CKT
In Commercial Distribution

  • 10709078002943 ()
  • 00709078002946 ()


  • Anaesthesia breathing circuit, single-use
PSDV-SG is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the U.S. The product consists of a loading unit which includes two buttresses. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch. PSDV-SG is MR Safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PSDA60ECHTHN
In Commercial Distribution

  • 50085412658860 ()
  • 00085412658865 ()

  • Length: 60 Millimeter
PSDA60ECHTHN

  • Staple line-reinforcement strip
PSDV-SG is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the U.S. The product consists of a loading unit which includes two buttresses. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch. PSDV-SG is MR Safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PSDA45ECHTHN
In Commercial Distribution

  • 50085412658853 ()
  • 00085412658858 ()

  • Length: 45 Millimeter
PSDA45ECHTHN

  • Staple line-reinforcement strip
PSDV-SG is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the U.S. The product consists of a loading unit which includes two buttresses. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch. PSDV-SG is MR Safe
SYNOVIS LIFE TECHNOLOGIES, INC.
PSDA60GIATHN
In Commercial Distribution

  • 50085412658846 ()
  • 00085412658841 ()

  • Length: 60 Millimeter
PSDA60GIATHN

  • Staple line-reinforcement strip
PSDV-SG is prepared from dehydrated bovine pericardium procured from cattle under 30 months of age in the U.S. The product consists of a loading unit which includes two buttresses. Each buttress has acrylic adhesive on one side for attachment to the stapler surfaces. Each PSDV-SG loading unit is packaged sterile in a separate pouch. PSDV-SG is MR Safe.
SYNOVIS LIFE TECHNOLOGIES, INC.
PSDA45GIATHN
In Commercial Distribution

  • 50085412658839 ()
  • 00085412658834 ()

  • Length: 45 Millimeter
PSDA45GIATHN

  • Staple line-reinforcement strip
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