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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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OPELAIII Dedicated AC Adapter - 14589864500138

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500138 ()


  • Head-worn lamp

OPELAIII Battery Unit - 14589864500121

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500121 ()


  • Head-worn lamp

OPELAIII Attached Belt (3L) - 14589864500350

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500350 ()


  • Head-worn lamp

OPELAIII Hard Case - 14589864500237

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500237 ()


  • Head-worn lamp

OPELAIII Cord Clip (Small) - 14589864500206

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500206 ()


  • Head-worn lamp

OPELAIII Antibacterial Urethane Pad - 14589864500176

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
Not in Commercial Distribution

  • 14589864500176 ()


  • Head-worn lamp

OPELAIII Main Unit - 14589864500114

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500114 ()


  • Head-worn lamp

OPELAIII Standard Package - 14589864500107

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500107 ()


  • Head-worn lamp

Endovenous Radiofrequency Ablation (RFA) Catheter - 08600360005107

Endovenous Radiofrequency Ablation (RFA) Catheter 7-60
Vein360 LLC
VEN-7-60
Not in Commercial Distribution

  • 08600360005107 ()
VEN-7-60

  • Radio-frequency ablation system

Endovenous Radiofrequency Ablation (RFA) Catheter - 08600360005022

Endovenous Radiofrequency Ablation (RFA) Catheter 3-60
Vein360 LLC
VEN-3-60
Not in Commercial Distribution

  • 08600360005022 ()
VEN-3-60

  • Radio-frequency ablation system

Endovenous Radiofrequency Ablation (RFA) Catheter - 08600360005008

Endovenous Radiofrequency Ablation (RFA) Catheter 7-100
Vein360 LLC
VEN-7-100
Not in Commercial Distribution

  • 08600360005008 ()
VEN-7-100

  • Radio-frequency ablation system

Flotec - B741RW0

No Description
FLOTEC INC
RW Regulator
In Commercial Distribution

  • B741RW0 ()


  • Non-fixed medical gas cylinder regulator

Flotec - B741MC0

No Description
FLOTEC INC
Mass Casualty Assembly
In Commercial Distribution

  • B741MC0 ()


  • High-pressure medical gas hose
  • Medical gas flowmeter, dial-type
  • Non-fixed medical gas cylinder regulator

Flotec - B741FM0

No Description
FLOTEC INC
Flowmeter
In Commercial Distribution

  • B741FM0 ()


  • Medical gas flowmeter, dial-type

Flotec - B741DL0

No Description
FLOTEC INC
InGage Regulator
In Commercial Distribution

  • B741DL0 ()


  • Non-fixed medical gas cylinder regulator

Freezpen® - B386CLN2O8GUNBOX1

No Description
H & O Equipments SA
8g cartridges for Freezpen
In Commercial Distribution

  • B386CLN2O8GUNCARTON2 ()
  • B386CLN2O8GUNBOX1 ()
  • B386CLN2O8GUNBOX0 ()
CL-N2O-8G-UNBOX

  • General cryosurgical system, cryogen gas, mechanical

Freezpen - B386CLN2O8GBOX1

No Description
H & O Equipments SA
8g N2O cartridges for Freezpen
In Commercial Distribution

  • B386CLN2O8GCARTON2 ()
  • B386CLN2O8GBOX1 ()
  • B386CLN2O8GBOX0 ()
CL-N2O-8G-BOX

  • Nitrous oxide gas cartridge

Freezpen® - B386CLN2O16GUNBOX1

No Description
H & O Equipments SA
16g cartridges for Freezpen
In Commercial Distribution

  • B386CLN2O16GUNCARTON2 ()
  • B386CLN2O16GUNBOX1 ()
  • B386CLN2O16GUNBOX0 ()
CL-N2O-16G-UNBOX

  • General cryosurgical system, cryogen gas, mechanical

Freezpen® - B386CLFPU180

No Description
H & O Equipments SA
Freezpen 16G
In Commercial Distribution

  • B386CLFPU180 ()
CL-FPU-18

  • Nitrous oxide gas cartridge

Freezpen® - B386CLFPU020

No Description
H & O Equipments SA
Freezpen 8G
In Commercial Distribution

  • B386CLFPU020 ()
CL-FPU-02

  • Nitrous oxide gas cartridge

Freezpen® - B386CLFP160

No Description
H & O Equipments SA
Freezpen 16G
In Commercial Distribution

  • B386CLFP160 ()
CL-FP-16

  • Nitrous oxide gas cartridge

Freezpen® - B386CLFP010

No Description
H & O Equipments SA
Freezpen 8G
In Commercial Distribution

  • B386CLFP010 ()
CL-FP-01

  • Nitrous oxide gas cartridge

Freezpen - B386CLFP000

No Description
H & O Equipments SA
Freezpen
In Commercial Distribution

  • B386CLFP000 ()
CL-FP-00

  • General cryosurgical system, cryogen gas, mechanical

IPD - 08435566600937

Scan abutment Non-Engaging Ø 5,1 H 10.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566600937 ()
IPD/AA-SW-01

  • Dental implant abutment analog, intraoral-scanning, single-use

IPD - 08435566600920

Scan abutment Engaging Ø 5,1 H 10.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566600920 ()
IPD/AA-SW-00

  • Dental implant abutment analog, intraoral-scanning, single-use

IPD - 08435566600913

Scan abutment Engaging Ø 4,1 H 15.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566600913 ()
IPD/AA-SR-02

  • Dental implant abutment analog, intraoral-scanning, single-use

IPD - 08435566600906

Scan abutment Non-Engaging Ø 4,1 H 10.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566600906 ()
IPD/AA-SR-01

  • Dental implant abutment analog, intraoral-scanning, single-use

IPD - 08435566600890

Scan abutment Engaging Ø 4,1 H 10.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566600890 ()
IPD/AA-SR-00

  • Dental implant abutment analog, intraoral-scanning, single-use

IPD - 08435566600883

Scan abutment Engaging Ø 3,5 H 15.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566600883 ()
IPD/AA-SN-02

  • Dental implant abutment analog, intraoral-scanning, single-use

IPD - 08435566600876

Scan abutment Non-Engaging Ø 3,5 H 10.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566600876 ()
IPD/AA-SN-01

  • Dental implant abutment analog, intraoral-scanning, single-use

IPD - 08435566600869

Scan abutment Engaging Ø 3,5 H 10.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566600869 ()
IPD/AA-SN-00

  • Dental implant abutment analog, intraoral-scanning, single-use

IPD - 08435566600852

Castable Non-Engaging Ø 5,1
IMPLANT PROTESIS DENTAL 2004 SL
CA
In Commercial Distribution

  • 08435566600852 ()
IPD/AA-RW-00

  • Dental casting unit

IPD - 08435566600845

Castable Non-Engaging Ø 4,1
IMPLANT PROTESIS DENTAL 2004 SL
CA
In Commercial Distribution

  • 08435566600845 ()
IPD/AA-RR-00

  • Dental casting unit

IPD - 08435566600821

Non-engaging Ti temporary abutment Ø 5.1
IMPLANT PROTESIS DENTAL 2004 SL
PP
In Commercial Distribution

  • 08435566600821 ()
IPD/AA-PW-07

  • Dental implant suprastructure, temporary, preformed, single-use

IPD - 08435566600814

Engaging Ti temporary abutment Ø 5.1
IMPLANT PROTESIS DENTAL 2004 SL
PP
In Commercial Distribution

  • 08435566600814 ()
IPD/AA-PW-06

  • Dental implant suprastructure, temporary, preformed, single-use

IPD - 08435566600807

Non-engaging Ti temporary abutment Ø 4.1
IMPLANT PROTESIS DENTAL 2004 SL
PP
In Commercial Distribution

  • 08435566600807 ()
IPD/AA-PR-07

  • Dental implant suprastructure, temporary, preformed, single-use

IPD - 08435566600791

Engaging Ti temporary abutment Ø 4.1
IMPLANT PROTESIS DENTAL 2004 SL
PP
In Commercial Distribution

  • 08435566600791 ()
IPD/AA-PR-06

  • Dental implant suprastructure, temporary, preformed, single-use

IPD - 08435566600784

Cementing abutment Non-Engaging 25° Ø 4,1 H 2.0
IMPLANT PROTESIS DENTAL 2004 SL
PC
In Commercial Distribution

  • 08435566600784 ()
IPD/AA-PR-05

  • Dental implant suprastructure, permanent, preformed

IPD - 08435566600777

Cementing abutment Engaging 15° Ø 4,1 H 2.0
IMPLANT PROTESIS DENTAL 2004 SL
PC
In Commercial Distribution

  • 08435566600777 ()
IPD/AA-PR-04

  • Dental implant suprastructure, permanent, preformed

IPD - 08435566600760

Cementing abutment Non-Engaging 25° Ø 4,1 H 1.0
IMPLANT PROTESIS DENTAL 2004 SL
PC
In Commercial Distribution

  • 08435566600760 ()
IPD/AA-PR-03

  • Dental implant suprastructure, permanent, preformed
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