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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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Bioplate® - M3848135760

Self-Drilling Screw - Ø1.5 mm x 4 mm (2) [10 PK]
Bioplate, Inc.
81-3576
In Commercial Distribution

  • M3848135761 ()
  • M3848135760 ()
81-3576

  • Craniofacial bone screw, non-bioabsorbable

PlasmaJet Neutral Plasma Surgery System - M397OSCP05120

Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
OS-CP-05-12
In Commercial Distribution

  • M397OSCP05120 ()
  • M397OSCP05122 ()

  • Length: 12 Centimeter
OS-CP-05-12

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397OSCP0507H0

Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
OS-CP 05-07H
In Commercial Distribution

  • M397OSCP0507H2 ()
  • M397OSCP0507H0 ()

  • Length: 07 Centimeter
OS-CP 05-07H

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397OSCP05070

Single-Use Cut/Coagulation Handpiece for Open Surgery for PlasmaJet System
PLASMA SURGICAL, INC
OS-CP-05-07
In Commercial Distribution

  • M397OSCP05070 ()
  • M397OSCP05072 ()

  • Length: 7 Centimeter
OS-CP-05-07

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397OSCG0512H0

Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
OS-CG 05-12H
In Commercial Distribution

  • M397OSCG0512H2 ()
  • M397OSCG0512H0 ()

  • Length: 12 Centimeter
OS-CG 05-12H

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397OSCG05120

Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
OS-CG-05-12
In Commercial Distribution

  • M397OSCG05120 ()
  • M397OSCG05122 ()

  • Length: 12 Centimeter
OS-CG-05-12

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397OSCG0507H0

Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
OS-CG 05-07H
In Commercial Distribution

  • M397OSCG0507H2 ()
  • M397OSCG0507H0 ()

  • Length: 7 Centimeter
OS-CG 05-07H

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397OSCG05070

Single-Use Cut/Coagulation Handpiece for Open Surgery for PlasmaJet System
PLASMA SURGICAL, INC
OS-CG-05-07
In Commercial Distribution

  • M397OSCG05072 ()
  • M397OSCG05070 ()

  • Length: 7 Centimeter
OS-CG-05-07

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397LSCP0528H0

Single-Use Cut/Coagulation Handpiece for Laparoscopic Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
LS-CP 05-28H
In Commercial Distribution

  • M397LSCP0528H2 ()
  • M397LSCP0528H0 ()

  • Length: 28 Centimeter
LS-CP 05-28H

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397LSCG0528H0

Single-Use Cut/Coagulation Handpiece for Laparoscopic Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
LS-CG 05-28H
In Commercial Distribution

  • M397LSCG0528H2 ()
  • M397LSCG0528H0 ()

  • Length: 28 Centimeter
LS-CG 05-28H

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M3970SCP0512H0

Single-use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
OS-CP 05-12H
In Commercial Distribution

  • M397OSCP0512H2 ()
  • M3970SCP0512H0 ()

  • Length: 12 Centimeter
OS-CP 05-12H

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397SCDU280

Single-Use Cut/Coagulation Handpiece for Laparoscopic Surgery for the PlamaJet System
PLASMA SURGICAL, INC
S-CDU+28
In Commercial Distribution

  • M397SCDU280 ()
  • M397SCDU282 ()

  • Length: 28 Centimeter
S-CDU-28

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397SCDU120

Single-Use Cut/Coagulation Handpiece for Open Surgery Handpiece for the PlasmaJet System
PLASMA SURGICAL, INC
S-CDU+12
In Commercial Distribution

  • M397SCDU120 ()
  • M397SCDU122 ()

  • Length: 12 Centimeter
S-CDU-12

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397SCDU070

Single-Use Cut/Coagulation Handpiece for Open Surgical for the PlasmaJet System
PLASMA SURGICAL, INC
S-CDU+07
In Commercial Distribution

  • M397SCDU070 ()
  • M397SCDU072 ()

  • Length: 7 Centimeter
S-CDU-07

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397LSCP05280

Single-Use Cut/Coagulation Handpiece for the Laparoscopic Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
LS-CP-05-28
In Commercial Distribution

  • M397LSCP05280 ()
  • M397LSCP05282 ()

  • Length: 28 Centimeter
LS-CP-05-28

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397LSCG05280

Single-Use Cut/Coagulation Handpiece for Laparoscopic Surgery for PlamaJet System
PLASMA SURGICAL, INC
LS-CG-05-28
In Commercial Distribution

  • M397LSCG05280 ()
  • M397LSCG05282 ()

  • Length: 28 Centimeter
LS-CG-05-28

  • Plasma surgical system handpiece

Holster Option - M397HO280

Holster (Accessory) use for the Handpiece Holder
PLASMA SURGICAL, INC
HO-28
In Commercial Distribution

  • M397HO280 ()
  • M397HO282 ()

  • Length: 28 Centimeter
HO-28

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397GCDU280

Single-Use Cut/Coagulation Handpiece for Laparosopic Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
G-CDU+28
In Commercial Distribution

  • M397GCDU280 ()
  • M397GCDU282 ()

  • Length: 28 Centimeter
G-CDU-28

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397GCDU120

Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
G-CDU+12
In Commercial Distribution

  • M397GCDU120 ()
  • M397GCDU122 ()

  • Length: 12 Centimeter
G-CDU-12

  • Plasma surgical system handpiece

PlasmaJet Neutral Plasma Surgery System - M397GCDU070

Single-Use Cut/Coagulation Handpiece for Open Surgery for the PlasmaJet System
PLASMA SURGICAL, INC
G-CDU+07
In Commercial Distribution

  • M397GCDU070 ()
  • M397GCDU072 ()

  • Length: 7 Centimeter
G-CDU-07

  • Plasma surgical system handpiece

IPS e.max Press - DIVO7166261

dental abutments
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
716626
In Commercial Distribution

  • DVIV7166260 ()
  • DIVO7166261 ()
  • DIVO7166262 ()
716626

  • Dental implant suprastructure, permanent, preformed

IPS e.max Press - DIVO7166251

dental abutments
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
716625
In Commercial Distribution

  • DVIV7166250 ()
  • DIVO7166251 ()
  • DIVO7166252 ()
716625

  • Dental implant suprastructure, permanent, preformed

IPS e.max Press - DIVO7166241

dental abutments
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
716624
In Commercial Distribution

  • DVIV7166240 ()
  • DIVO7166241 ()
  • DIVO7166242 ()
716624

  • Dental implant suprastructure, permanent, preformed

IPS e.max Press - DIVO7119811

dental abutments
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
711981
In Commercial Distribution

  • DVIV7119810 ()
  • DIVO7119811 ()
  • DIVO7119812 ()
711981

  • Dental implant suprastructure, permanent, preformed

Systemp.inlay Systemp.onlay - DVIV559586AN1

Systemp.inlay Refill 3x2,5 g Universal
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
559586AN
Not in Commercial Distribution

  • DVIV559586AN1 ()
  • DVIV559586AN0 ()
  • DVIV559586AN2 ()
559586AN

  • Dental composite resin

Heliosit - DVIV532629AN1

Heliosit Orthodontic Refill 3x2,5 g
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
532629AN
Not in Commercial Distribution

  • DVIV532629AN1 ()
  • DVIV532629AN0 ()
  • DVIV532629AN2 ()
532629AN

  • Orthodontic bracket adhesive

DRY320 - DRY320

A device to store and dry endoscopes
Wassenburg Medical, Inc.
DRY320
Not in Commercial Distribution

  • G434DRY320 ()
  • DRY320 ()


  • Endoscope drying/storage cabinet

ArcScan Insight 100 - B017ED102

No Description
ARCSCAN, INC.
EyeSeal Disposable
In Commercial Distribution

  • B017ED113 ()
  • B017ED102 ()
ED1

  • Ophthalmic ultrasound imaging system

Accuro - B015000010

No Description
RIVANNA MEDICAL, LLC
00001
In Commercial Distribution

  • B015000010 ()
  • B015000011 ()


  • Hand-held ultrasound imaging system, body-surface

OCS Liver System - B00944823

OCS Liver Perfusion Initiation Set
TRANSMEDICS, INC.
3400
In Commercial Distribution

  • B00944895 ()
  • B00944823 ()

  • Length: 18 Inch
  • Width: 12 Inch
  • Height: 4 Inch
3400

  • Donor-organ preservation/transport perfusion initiation/termination set
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