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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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i.Series® - 00816394020780

Platelet Incubator
HELMER, INC.
PC4200i
In Commercial Distribution

  • 00816394020780 ()


  • Platelet incubator

i.Series® - 00816394020773

Platelet Incubator
HELMER, INC.
PC3200i
In Commercial Distribution

  • 00816394020773 ()


  • Platelet incubator

i.Series® - 00816394020766

Platelet Incubator
HELMER, INC.
PC2200i
In Commercial Distribution

  • 00816394020766 ()


  • Platelet incubator

i.Series® - 00816394020759

Platelet Incubator
HELMER, INC.
PC1200i
Not in Commercial Distribution

  • 00816394020759 ()


  • Platelet incubator

i.Series® - 00816394020742

Platelet Incubator
HELMER, INC.
PC900i
Not in Commercial Distribution

  • 00816394020742 ()


  • Platelet incubator

i.Series® - 00816394020735

Platelet Incubator
HELMER, INC.
PC100i
Not in Commercial Distribution

  • 00816394020735 ()


  • Platelet incubator

Horizon Series™ - 00816394020728

Platelet Incubator
HELMER, INC.
PC4200h
In Commercial Distribution

  • 00816394020728 ()


  • Platelet incubator

Horizon Series™ - 00816394020711

Platelet Incubator
HELMER, INC.
PC3200h
In Commercial Distribution

  • 00816394020711 ()


  • Platelet incubator

Horizon Series™ - 00816394020704

Platelet Incubator
HELMER, INC.
PC2200h
In Commercial Distribution

  • 00816394020704 ()


  • Platelet incubator

Horizon Series™ - 00816394020698

Platelet Incubator
HELMER, INC.
PC1200h
Not in Commercial Distribution

  • 00816394020698 ()


  • Platelet incubator

Horizon Series™ - 00816394020681

Platelet Incubator
HELMER, INC.
PC900h
Not in Commercial Distribution

  • 00816394020681 ()


  • Platelet incubator

Horizon Series™ - 00816394020674

Platelet Incubator
HELMER, INC.
PC100h
Not in Commercial Distribution

  • 00816394020674 ()


  • Platelet incubator

Helmer - 00816394021688

Environmental chamber for storage of platelet concentrate
HELMER, INC.
PC2200-Pro
In Commercial Distribution

  • 00816394021688 ()


  • Platelet incubator

Helmer - 00816394021671

Environmental chamber for storage of platelet concentrate
HELMER, INC.
PC3200-PRO
In Commercial Distribution

  • 00816394021671 ()


  • Platelet incubator

Helmer - 00816394021664

Environmentatal chamber for storage of platelet concentrate
HELMER, INC.
PC4200-Pro
In Commercial Distribution

  • 00816394021664 ()


  • Platelet incubator

MEDI - 00636257156186

TG 8MM 3# FOAM CONDYLAR BK/BK HOOK
MEDI MANUFACTURING, INC.
201561
In Commercial Distribution

  • 00636257156186 ()


  • Knee support orthosis

Power Dental USA - D9432001T00

SURGICAL CHISELS 13K/TG TITANIUM 3.5 / 3 mm
Power Dental U.S.A. Inc.
2001T
In Commercial Distribution

  • D9432001T00 ()
2001T

  • Dressing/utility forceps, scissors-like, reusable
  • Periodontal hoe

TITAN IMPLANTS, INC. - 00842448112347

Titan Design 4.8mm Tg Hex Abutment Analog Aluminum
TITAN IMPLANT INC
TN-48TGHAA-AL
In Commercial Distribution

  • 00842448112347 ()


  • Dental implant abutment analog, laboratory

XiVE® - EFRI322596002

XiVE® TG Lab Set Gold Bar Coping
Dentsply Implants Manufacturing GmbH
32259600
Not in Commercial Distribution

  • EFRI322596002 ()
25-9600

  • Dental implant suprastructure kit

XiVE® - EFRI322593012

XiVE® TG Lab Set Soldering Analog Bar
Dentsply Implants Manufacturing GmbH
32259301
Not in Commercial Distribution

  • EFRI322593012 ()
25-9301

  • Dental implant suprastructure kit

XiVE® - EFRI322593002

XiVE® TG Lab Set Soldering Analog Bridge
Dentsply Implants Manufacturing GmbH
32259300
Not in Commercial Distribution

  • EFRI322593002 ()
25-9300

  • Dental implant suprastructure kit

XiVE® - EFRI322541062

XiVE® TG Lab Set Soldering Analog Bar
Dentsply Implants Manufacturing GmbH
32254106
Not in Commercial Distribution

  • EFRI322541062 ()
25-4106

  • Dental implant suprastructure kit

XiVE® - EFRI322541052

XiVE® TG Lab Set Soldering Analog Bridge
Dentsply Implants Manufacturing GmbH
32254105
Not in Commercial Distribution

  • EFRI322541052 ()
25-4105

  • Dental implant suprastructure kit

Micro Needle Holder TG Cvd 20 cm (8") - 10840199505019

Micro Needle Holder TG Cvd 20 cm (8")
KOROS U.S.A., INC.
7010-17
In Commercial Distribution

  • 00840199505012 ()
  • 10840199505019 ()
7010-17

  • Suturing needle holder, reusable

POST SCREWS M 2 - D7700874893

POST SCREWS M 2 PRE-KOH TG, MAGENTA (10PCS)
SWEDEN & MARTINA SPA
A-TG-VM-200-10
In Commercial Distribution

  • D7700874893 ()
A-TG-VM-200-10

  • Dental implant suprastructure, permanent, preformed

POST SCREWS M 1.8 - D7700874883

POST SCREWS M 1.8 PRE-KOH TG, GREEN (10PCS)
SWEDEN & MARTINA SPA
A-TG-VM-180-10
In Commercial Distribution

  • D7700874883 ()
A-TG-VM-180-10

  • Dental implant suprastructure, permanent, preformed

PRE-MADE REP. POST STRAIGHT - D7700874773

PRE-MADE REP. POST STRAIGHT PROF.,H7, PREKOH TG
SWEDEN & MARTINA SPA
A-TG-MR-W-70
In Commercial Distribution

  • D7700874773 ()
A-TG-MR-W-70

  • Dental implant suprastructure, permanent, preformed

PRE-MADE REP. POST STRAIGHT - D7700874763

PRE-MADE REP. POST STRAIGHT PROF.,H7, PREKOH TG
SWEDEN & MARTINA SPA
A-TG-MR-M-70
In Commercial Distribution

  • D7700874763 ()
A-TG-MR-M-70

  • Dental implant suprastructure, permanent, preformed

PRE-MADE REP. POST STRAIGHT - D7700874753

PRE-MADE REP. POST STRAIGHT PROF.,H4, PREKOH TG
SWEDEN & MARTINA SPA
A-TG-MR-W-40
In Commercial Distribution

  • D7700874753 ()
A-TG-MR-W-40

  • Dental implant suprastructure, permanent, preformed

PRE-MADE REP. POST STRAIGHT - D7700874743

PRE-MADE REP. POST STRAIGHT PROF.,H4, PREKOH TG
SWEDEN & MARTINA SPA
A-TG-MR-M-40
In Commercial Distribution

  • D7700874743 ()
A-TG-MR-M-40

  • Dental implant suprastructure, permanent, preformed
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