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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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IPD - 08435566608759

Custom Ti Base Non-Engaging Ø 3,3 H 2.5
IMPLANT PROTESIS DENTAL 2004 SL
INC3D
In Commercial Distribution

  • 08435566608759 ()
IPD/DB-IN-05/3D

  • Dental implant suprastructure, permanent, preformed

IPD - 08435566608742

Custom Ti Base Engaging Ø 3,3 H 2.5
IMPLANT PROTESIS DENTAL 2004 SL
INC3D
In Commercial Distribution

  • 08435566608742 ()
IPD/DB-IN-04/3D

  • Dental implant suprastructure, permanent, preformed

IPD - 08435566608735

Custom Ti Base Non-Engaging Ø 3,3 H 1.5
IMPLANT PROTESIS DENTAL 2004 SL
INC3D
In Commercial Distribution

  • 08435566608735 ()
IPD/DB-IN-03/3D

  • Dental implant suprastructure, permanent, preformed

IPD - 08435566608711

Custom Ti Base Engaging Ø 3,3 H 1.5
IMPLANT PROTESIS DENTAL 2004 SL
INC3D
In Commercial Distribution

  • 08435566608711 ()
IPD/DB-IN-02/3D

  • Dental implant suprastructure, permanent, preformed

IPD - 08435566608698

Custom Ti Base Non-Engaging Ø 3,3 H 0.5
IMPLANT PROTESIS DENTAL 2004 SL
INC3D
In Commercial Distribution

  • 08435566608698 ()
IPD/DB-IN-01/3D

  • Dental implant suprastructure, permanent, preformed

IPD - 08435566608674

Custom Ti Base Engaging Ø 3,3 H 0.5
IMPLANT PROTESIS DENTAL 2004 SL
INC3D
In Commercial Distribution

  • 08435566608674 ()
IPD/DB-IN-00/3D

  • Dental implant suprastructure, permanent, preformed

IPD - 08435566608650

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

  • 08435566608650 ()
IPD/DB-HR-00

  • Dental casting unit

IPD - 08435566608391

Digital analog Ø 4,1
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566608391 ()
IPD/DB-AR-00/3D

  • Dental implant analog

IPD - 08435566608384

Analog Ø 4,1
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566608384 ()
IPD/DB-AR-00

  • Dental implant analog

IPD - 08435566608377

Digital analog Ø 3,3
IMPLANT PROTESIS DENTAL 2004 SL
AND3D
In Commercial Distribution

  • 08435566608377 ()
IPD/DB-AN-00/3D

  • Dental implant analog

IPD - 08435566608360

Analog Ø 3,3
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566608360 ()
IPD/DB-AN-00

  • Dental implant analog

IPD - 08435566608353

TPA Screw M2 Direct
IMPLANT PROTESIS DENTAL 2004 SL
TPA
In Commercial Distribution

  • 08435566608353 ()
IPD/DA-TR-51

  • Dental prosthesis/implant abutment screw

Fifty50 Sport - 00892896000260

Fifty50 Sport Blood Glucose Monitoring System 2.0
i-SENS, Inc.
163424-201
In Commercial Distribution

  • 00892896000260 ()
  • 10892896000267 ()


  • Home-use/point-of-care blood glucose monitoring system IVD

Fifty50 - 00892896000086

Fifty50 Blood Glucose Monitoring System 2.0
i-SENS, Inc.
163308-302
In Commercial Distribution

  • 10892896000083 ()
  • 00892896000086 ()


  • Home-use/point-of-care blood glucose monitoring system IVD

Fifty50 - 00892896000093

Fifty50 Blood Glucose Test Strip
i-SENS, Inc.
163604
In Commercial Distribution

  • 20892896000097 ()
  • 10892896000090 ()
  • 00892896000093 ()
  • 50892896000098 ()


  • Glucose IVD, reagent

Fifty50 - 00892896000017

Fifty50 Blood Glucose Test Strip
i-SENS, Inc.
163140
In Commercial Distribution

  • 20892896000011 ()
  • 10892896000014 ()
  • 00892896000017 ()
  • 50892896000012 ()


  • Glucose IVD, reagent

MGB Alert Internal Control Set IC2-480 rxn - 03661540951411

The MGB Alert Internal Control Set IC2 consists of reagents intended for use as an unassayed internal extraction and amplification process control in any real-time polymerase chain reaction (PCR) assay. The Internal Control Set IC2 can be used to detect systemic variation that may arise during the extraction and amplification process associated with real-time PCR assays. The set is not intended to monitor other real-time PCR processes.
Elitechgroup Mdx LLC
800362
In Commercial Distribution

  • 03661540951411 ()
800362

  • Exogenous DNA/RNA internal control IVD, kit

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

Dr.MUSIC - 00193026000007

No Description
SMART MEDICAL DEVICE Co., Ltd.
DM-VME03s
Not in Commercial Distribution

  • 00193026000007 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system

SCOOP - B181C9HF20

Transtracheal Catheters and Cleaning Rods (Two Pack) 9cm
TRANSTRACHEAL SYSTEMS, INC.
C-9HF-2
In Commercial Distribution

  • B181C9HF20 ()
C-9HF-2

  • Oxygen administration transtracheal catheter

SCOOP - B181C920

Transtracheal Catheters and Cleaning Rods (Two Pack) 9cm
TRANSTRACHEAL SYSTEMS, INC.
C-9-2
In Commercial Distribution

  • B181C920 ()
C-9-2

  • Oxygen administration transtracheal catheter

SCOOP - B181C90

Transtracheal Catheter and Cleaning Rod (Single Pack) 9cm
TRANSTRACHEAL SYSTEMS, INC.
C-9
In Commercial Distribution

  • B181C90 ()
C-9

  • Oxygen administration transtracheal catheter

SCOOP - B181C11HF20

Transtracheal Catheters and Cleaning Rods (Two Pack) 11cm
TRANSTRACHEAL SYSTEMS, INC.
C-11HF-2
In Commercial Distribution

  • B181C11HF20 ()
C-11HF-2

  • Oxygen administration transtracheal catheter

SCOOP - B181C1120

Transtracheal Catheters and Cleaning Rods (Two Pack) 11cm
TRANSTRACHEAL SYSTEMS, INC.
C-11-2
In Commercial Distribution

  • B181C1120 ()
C-11-2

  • Oxygen administration transtracheal catheter

SCOOP - B181C110

Transtracheal Catheter and Cleaning Rod (Single Pack) 11cm
TRANSTRACHEAL SYSTEMS, INC.
C-11
In Commercial Distribution

  • B181C110 ()
C-11

  • Oxygen administration transtracheal catheter

Medical Reverse Osmosis - B297KROUPT5600

UPT-560 Medical RO - 6 Membrane - 10 gpm Permeate Production
SPECIALITY WATER TECHNOLOGY
K-RO-UPT-560
In Commercial Distribution

  • B297KROUPT5600 ()


  • Reverse-osmosis water purification system

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

Airo™ CPAP Mask Liners - 30850054813313

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

  • 00850054813312 ()
  • 30850054813313 ()
EVAL-AS-100

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 30850054813306

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

  • 00850054813305 ()
  • 30850054813306 ()
EVAL-AM-100

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 30850054813283

Sample - Airo™ CPAP Mask Liners - Box of 25 - Large
Athfar 828 Inc
SMPL-AL-25
In Commercial Distribution

  • 00850054813282 ()
  • 30850054813283 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 30850054813245

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

  • 00850054813244 ()
  • 30850054813245 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 30850054813207

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

  • 00850054813206 ()
  • 30850054813207 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 30850054813115

Sample - Airo™ CPAP Mask Liners - Box of 25 - Large
Athfar 828 Inc
SMPL-AL-25
Not in Commercial Distribution

  • 00850054813114 ()
  • 30850054813115 ()
SMPL-AL-25

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 30850054813108

Sample - Airo™ CPAP Mask Liners - Box of 25 - Medium
Athfar 828 Inc
SMPL-AM-25
Not in Commercial Distribution

  • 00850054813107 ()
  • 30850054813108 ()
SMPL-AM-25

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 30850054813092

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

  • 00850054813091 ()
  • 30850054813092 ()
SMPL-AS-25

  • General-purpose medical fibre padding

Freezpen® - 15407008484504

No Description
H & O Equipments SA
35g cartridges for Freezpen
In Commercial Distribution

  • 25407008484501 ()
  • 15407008484504 ()
  • 05407008484507 ()
CL-N2O-35G-UBOX

  • General cryosurgical system, cryogen gas, mechanical

Freezpen® - 15407008484306

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

  • 25407008484303 ()
  • 15407008484306 ()
  • 05407008484309 ()
CL-N2O-16G-UNBOX

  • General cryosurgical system, cryogen gas, mechanical

Freezpen® - 15407008484207

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

  • 25407008484204 ()
  • 15407008484207 ()
  • 05407008484200 ()
CL-N2O-16G-BOX

  • General cryosurgical system, cryogen gas, mechanical

Freezpen® - 15407008484108

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

  • 25407008484105 ()
  • 15407008484108 ()
  • 05407008484101 ()
CL-N2O-8G-UNBOX

  • General cryosurgical system, cryogen gas, mechanical

Freezpen® - 15407008484009

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

  • 25407008484006 ()
  • 15407008484009 ()
  • 05407008484002 ()
CL-N2O-8G-BOX

  • General cryosurgical system, cryogen gas, mechanical

Freezpen® - 15407008483514

No Description
H & O Equipments SA
Freezpen 35g
In Commercial Distribution

  • 15407008483514 ()
CL-FPU-36

  • General cryosurgical system, cryogen gas, mechanical

Freezpen® - 15407008483507

No Description
H & O Equipments SA
Freezpen 35G
In Commercial Distribution

  • 15407008483507 ()
CL-FPU-35

  • General cryosurgical system, cryogen gas, mechanical

Freezpen® - 15407008483316

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

  • 15407008483316 ()
CL-FPU-19

  • General cryosurgical system, cryogen gas, mechanical
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