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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 - 08435566619564

Analog S2
IMPLANT PROTESIS DENTAL 2004 SL
AN
In Commercial Distribution

  • 08435566619564 ()
IPD/NA-AN-00

  • Dental implant analog

IPD - 08435566619557

Laboratory RA shank handle
IMPLANT PROTESIS DENTAL 2004 SL
LL
In Commercial Distribution

  • 08435566619557 ()
IPD/ML-00-70

  • Surgical screwdriver, reusable

IPD - 08435566619540

Clinical RA shank handle
IMPLANT PROTESIS DENTAL 2004 SL
LL
In Commercial Distribution

  • 08435566619540 ()
IPD/MC-00-16

  • Surgical screwdriver, reusable

IPD - 08435566619519

Open Tray Coping Screw Ø 4,25/5,0
IMPLANT PROTESIS DENTAL 2004 SL
TTI
In Commercial Distribution

  • 08435566619519 ()
IPD/MB-TR-00/C

  • Dental prosthesis/implant abutment screw analog, reusable

IPD - 08435566619472

Open Tray Coping Screw Ø 3,3/3,8
IMPLANT PROTESIS DENTAL 2004 SL
TTI
In Commercial Distribution

  • 08435566619472 ()
IPD/MB-TN-00/C

  • Dental prosthesis/implant abutment screw analog, reusable

IPD - 08435566619458

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

  • 08435566619458 ()
IPD/MB-ST-02

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

IPD - 08435566619441

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

  • 08435566619441 ()
IPD/MB-ST-01

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

IPD - 08435566619434

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

  • 08435566619434 ()
IPD/MB-ST-00

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

IPD - 08435566619427

Scan abutment Engaging Ø 4,25 H 15.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566619427 ()
IPD/MB-SR-02

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

IPD - 08435566619410

Scan abutment Non-Engaging Ø 4,25 H 10.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566619410 ()
IPD/MB-SR-01

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

IPD - 08435566619403

Scan abutment Engaging Ø 4,25 H 10.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566619403 ()
IPD/MB-SR-00

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

IPD - 08435566619397

Scan abutment Engaging Ø 3,8 H 15.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566619397 ()
IPD/MB-SN-02

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

IPD - 08435566619380

Scan abutment Non-Engaging Ø 3,8 H 10.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566619380 ()
IPD/MB-SN-01

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

IPD - 08435566619373

Scan abutment Engaging Ø 3,8 H 10.0
IMPLANT PROTESIS DENTAL 2004 SL
SC3D
In Commercial Distribution

  • 08435566619373 ()
IPD/MB-SN-00

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

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 - 00892896000093

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

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


  • Glucose IVD, reagent

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 - 00892896000017

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

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


  • Glucose IVD, reagent

Dr.MUSIC - 00193026000007

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

  • 00193026000007 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system

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

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

G5® - 00007469820231

The G5 Vibracare ZX1 Percussor is our durable, hand-held percussor used in respiratory therapy applications. Totally self-contained, and weighing less than three pounds, it provides optimal freedom of movement and portability with a ten foot hospital grade power cord. This model may be used with a variety of applicators and has a continuously-variable speed range of 20 - 50 cycles per second. This combination of applicators and speeds provides for a highly-versatile treatment range. It is the only hand-held percussor/massager to be granted C.S.A's highest medical operational rating. Comes with applicators 212, 216, 229, 230.
GENERAL PHYSIOTHERAPY INC
VIBRACARE ZX1
In Commercial Distribution

  • 00007469820231 ()

  • Weight: 6 Pound
VIBRACARE ZX1

  • Hand-held electric massager

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

Airo™ CPAP Mask Liners - 10850054813319

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

  • 00850054813312 ()
  • 10850054813319 ()
EVAL-AS-25

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 10850054813302

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

  • 00850054813305 ()
  • 10850054813302 ()
EVAL-AM-25

  • General-purpose medical fibre padding
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