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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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Airo™ CPAP Mask Liners - 00850054813374

Airo™ CPAP Mask Liners - Box of 25 - Small
Athfar 828 Inc
AS-25
In Commercial Distribution

  • 00850054813350 ()
  • 00850054813374 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813367

Airo™ CPAP Mask Liners - Box of 25 - Medium
Athfar 828 Inc
AM-25
In Commercial Distribution

  • 00850054813336 ()
  • 00850054813367 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813329

Evaluation Pack - Airo™ CPAP Mask Liners - Box of 50 - Large
Athfar 828 Inc
EVAL-AL-50
In Commercial Distribution

  • 00850054813299 ()
  • 00850054813329 ()
EVAL-AL-50

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813084

Airo™ CPAP Mask Liners - Box of 100 - Small
Athfar 828 Inc
AS-100
In Commercial Distribution

  • 00850054813350 ()
  • 00850054813084 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813077

Airo™ CPAP Mask Liners - Box of 100 - Medium
Athfar 828 Inc
AM-100
In Commercial Distribution

  • 00850054813336 ()
  • 00850054813077 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813060

Airo™ CPAP Mask Liners - Box of 100 - Large
Athfar 828 Inc
AL-100
In Commercial Distribution

  • 00850054813343 ()
  • 00850054813060 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813053

Airo™ CPAP Mask Liners - Box of 50 - Small
Athfar 828 Inc
AS-50
In Commercial Distribution

  • 00850054813350 ()
  • 00850054813053 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813046

Airo™ CPAP Mask Liners - Box of 50 - Medium
Athfar 828 Inc
AM-50
In Commercial Distribution

  • 00850054813336 ()
  • 00850054813046 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813022

Airo™ CPAP Mask Liners - Box of 50 - Large
Athfar 828 Inc
AL-50
In Commercial Distribution

  • 00850054813343 ()
  • 00850054813022 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813008

Airo™ CPAP Mask Liners - Box of 25 - Small
Athfar 828 Inc
AS-25
Not in Commercial Distribution

  • 00850054813121 ()
  • 00850054813008 ()
AS-25

  • General-purpose medical fibre padding

SurePass CTR NS Blade - 00860011634836

Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Blade
Dev4
CT-2003NS
In Commercial Distribution

  • 00860011634836 ()
  • 10860011634833 ()


  • Manual scalpel blade, reusable

LUMINELLE DTx Hysteroscopy System - 00853277008046

Hysteroscopy System indicated for both Hysteroscopy and Cystoscopy to permit direct viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
UVISION 360, INC.
LumDTX-A
In Commercial Distribution

  • 00853277008046 ()
20030

  • Flexible video cystoscope, reusable
  • Endoscope sheath, single-use
  • Flexible fibreoptic hysteroscope

OPELAIII COOLMAX® Comfort Inner Pads - 14589864500336

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500336 ()


  • Head-worn lamp

OPELAIII calibration kit - 14589864500312

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500312 ()


  • Head-worn lamp

OPELAIII Protected Special Package - 14589864500282

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500282 ()


  • Head-worn lamp

OPELAIII Protected Special Package - 14589864500275

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500275 ()


  • Head-worn lamp

OPELAIII Cord Clip (Large) - 14589864500213

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500213 ()


  • Head-worn lamp

OPELAIII Storage Bag (with calibration kit) - 14589864500169

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500169 ()


  • Head-worn lamp

OPELAIII Attached Belt (LL) - 14589864500152

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500152 ()


  • Head-worn lamp

OPELAIII Attached Belt (M-L) - 14589864500145

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500145 ()


  • Head-worn lamp

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
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