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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STAT PROFILE PHOX PLUS/C CONTROLS AUTO-CARTRIDGE, 75
NOVA BIOMEDICAL CORPORATION
PHOX PLUS/C
In Commercial Distribution

  • 00385480306430 ()
30643

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
OPEN TRAY TRANSFER SCREW M2 20 MM LONG, MAGENTA,PRE-KOH TG
SWEDEN & MARTINA SPA
A-TG-VTRA-200-20
In Commercial Distribution

  • D7700874693 ()
A-TG-VTRA-200-20

  • Dental implant suprastructure, permanent, preformed
OPEN TRAY TRANSFER SCREW M1.8 20 MM LONG, GREEN, PRE-KOH TG
SWEDEN & MARTINA SPA
A-TG-VTRA-180-20
In Commercial Distribution

  • D7700874683 ()
A-TG-VTRA-180-20

  • Dental implant suprastructure, permanent, preformed
CAST. NON REP. POST WITH GOLD BASE, PRE-KOH TG,WIDE PLATFORM
SWEDEN & MARTINA SPA
A-TG-UCABU-W-ROT
In Commercial Distribution

  • D7700884253 ()
A-TG-UCABU-W-ROT

  • Dental implant suprastructure, permanent, preformed
CAST. NON REP. POST WITH GOLD BASE, PRE-KOH TG, MEDIUM PLAT.
SWEDEN & MARTINA SPA
A-TG-UCABU-M-ROT
In Commercial Distribution

  • D7700884243 ()
A-TG-UCABU-M-ROT

  • Dental implant suprastructure, permanent, preformed
CAST. NON REP. POST WITH GOLD BASE, PRE-KOH TG, WIDE PLAT.
SWEDEN & MARTINA SPA
A-TG-UC-W-ROT
In Commercial Distribution

  • D7700884213 ()
A-TG-UC-W-ROT

  • Dental implant suprastructure, permanent, preformed
CAST. NON REP. POST WITH GOLD BASE, PRE-KOH TG, MEDIUM PLAT.
SWEDEN & MARTINA SPA
A-TG-UC-M-ROT
In Commercial Distribution

  • D7700884203 ()
A-TG-UC-M-ROT

  • Dental implant suprastructure, permanent, preformed
15GR ANGLE PRE-MADE POST, REP. H6 MM, PRE-KOH TG, WIDE PLAT.
SWEDEN & MARTINA SPA
A-TG-MAR15-W-60
In Commercial Distribution

  • D7700875783 ()
A-TG-MAR15-W-60

  • Dental implant suprastructure, permanent, preformed
15GR ANGLE PRE-MADE POST, REP. H6 MM, PRE-KOH TG,MEDIUM PLAT.
SWEDEN & MARTINA SPA
A-TG-MAR15-M-60
In Commercial Distribution

  • D7700875773 ()
A-TG-MAR15-M-60

  • Dental implant suprastructure, permanent, preformed
HEALING CAP FOR PRE-MADE POSTS H7 MM, PRE-KOH TG, WIDE PLAT.
SWEDEN & MARTINA SPA
A-TG-CAPGM-W-70
In Commercial Distribution

  • D7700874973 ()
A-TG-CAPGM-W-70

  • Dental implant suprastructure, permanent, preformed
HEALING CAP FOR PRE-MADE POSTS H7 MM, PRE-KOH TG,MEDIUM PLAT.
SWEDEN & MARTINA SPA
A-TG-CAPGM-M-70
In Commercial Distribution

  • D7700874963 ()
A-TG-CAPGM-M-70

  • Dental implant suprastructure, permanent, preformed
HEALING CAP FOR PRE-MADE POSTS H4 MM, PRE-KOH TG, WIDE PLAT.
SWEDEN & MARTINA SPA
A-TG-CAPGM-W-40
In Commercial Distribution

  • D7700874953 ()
A-TG-CAPGM-W-40

  • Dental implant suprastructure, permanent, preformed
HEALING CAP FOR PRE-MADE POSTS H4 MM, PRE-KOH TG,MEDIUM PLAT.
SWEDEN & MARTINA SPA
A-TG-CAPGM-M-40
In Commercial Distribution

  • D7700874943 ()
A-TG-CAPGM-M-40

  • Dental implant suprastructure, permanent, preformed
Vial Adapter 20mm FLL TG w/15 mic m Filter - VF
WEST PHARMA. SERVICES IL, . LTD
8072120
Not in Commercial Distribution

  • 27290108240270 ()
  • 17290108240273 ()
  • 37290108240277 ()
  • 07290108240276 ()


  • Vial/bottle adaptor, non-hermetic
Contra Angle 70:1
Nouvag AG
5065NOU
In Commercial Distribution

  • ENOU5065NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Contra Angle 16:1 Endodontics
Nouvag AG
5061NOU
In Commercial Distribution

  • ENOU5061NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Contra Angle 8:1 Endodontics
Nouvag AG
5057NOU
In Commercial Distribution

  • ENOU5057NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Contra Angle 32:1
Nouvag AG
5054NOU
In Commercial Distribution

  • ENOU5054NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Contra Angle 20:1 LED
Nouvag AG
5052nou
In Commercial Distribution

  • ENOU5052NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Contra Angle 1:1
Nouvag AG
5051NOU
In Commercial Distribution

  • ENOU5051NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Contra Angle 1:1
Nouvag AG
5050NOU
In Commercial Distribution

  • ENOU5050NOU0 ()


  • Line-powered dental drilling/sawing system handpiece
Clip for Contra Angle
Nouvag AG
1881
In Commercial Distribution

  • ENOU18819 ()
  • ENOU18810 ()


  • Line-powered dental drilling/sawing system handpiece
Base Mold 24 x 24 x 5 mm
SAKURA FINETEK U.S.A., INC.
4163
In Commercial Distribution

  • 00615233078100 ()
4163

  • Tissue embedding mould IVD, reusable
24 X 24 2 PLY DRAPE T180 MIST
Encompass Group, L.L.C.
CD0033
In Commercial Distribution

  • 50609953925986 ()
  • 00609953925981 ()


  • Patient surgical drape, reusable
IMS STERILIZATION WRAP 24 x 24 100 SHEET
HU-FRIEDY MFG. CO., LLC
IMS-1210H
In Commercial Distribution

  • 10889950002732 ()
  • 10889950075033 ()
IMS-1210H

  • Sterilization packaging, single-use
XPF® Patient Protection Shield, 24" x 24"
BLOXR Solutions, LLC
100210
In Commercial Distribution

  • 10811042030583 ()


  • Radiation shielding apron
Covex Sterile X-Ray Cassette Cover: 24" x 24"
Coulmed Products Group LLC
DI-5503
In Commercial Distribution

  • 30810087350100 ()
  • 10810087350106 ()
DI-5503

  • Medical equipment/instrument drape, single-use
24" DRYER, MED. GRAPHICS 24" DRYER, MED. GRAPHICS
PERMA PURE LLC
ME Series
In Commercial Distribution

  • 00840106901821 ()
  • 00840106901784 ()
  • 00840106901814 ()
  • 00840106901807 ()
  • 00840106901791 ()
ME-050-03-99

  • Gas-sampling/monitoring respiratory tubing, single-use
X-ray Cassette Cover 24 x 24 Adhesive Closure
MEDICAL TECHNIQUE, INC.
9954-50
In Commercial Distribution

  • 00815384022360 ()
  • 00815384022353 ()
  • 00815384022346 ()
9954-50

  • Instrument/equipment drape, single-use, sterile
BluEX-A (24 X 32 X 24 mm, 25°)
L&K BIOMED CO. ,LTD.
BA2432-2425S
In Commercial Distribution

  • 08809986465870 ()


  • Metallic spinal interbody fusion cage
Therapak Acetic Acid 24 Hour Collection (CS/24)
Therapak LLC
ACSK38533
In Commercial Distribution

  • 07312058462673 ()
ACSK38533

  • 24-hour urine specimen container IVD, preservative
No Description
BONART CO., LTD.
LCC-120A
In Commercial Distribution

  • 04719873120666 ()


  • Dental power tool system handpiece, line-powered
No Description
BONART CO., LTD.
LSC-101A
In Commercial Distribution

  • 04719873120215 ()


  • Dental power tool system handpiece, line-powered
METAL BRACKET ONLY FOR HANDPIECE HOLDER L/F
ACE SURGICAL SUPPLY CO., INC.
00320120
In Commercial Distribution

  • 00614950014217 ()
00320120

  • Dental power tool system handpiece, line-powered
THROTTLE LOCK DOWN STRAP FOR #0031717 & #0031720 FOOT PEDAL *AUTOCLAVABLE*
ACE SURGICAL SUPPLY CO., INC.
0031725
In Commercial Distribution

  • 00614950014200 ()
0031725

  • Dental power tool system handpiece, line-powered
EndoPilot retainer for apexcable
Schlumbohm GmbH & Co. KG
EDP2
In Commercial Distribution

  • 04260482990817 ()
110 2303

  • Dental power tool system handpiece, line-powered
AC/DC power supply for EndoPilot²
Schlumbohm GmbH & Co. KG
US
In Commercial Distribution

  • 04260482990787 ()
110 2203

  • Dental power tool system handpiece, line-powered
EndoPIlot wireless-footswitch, single
Schlumbohm GmbH & Co. KG
bluetooth
In Commercial Distribution

  • 04260482990602 ()
109 2361

  • Dental power tool system handpiece, line-powered
Wireless-Footswitchfor EndoPilot, twin
Schlumbohm GmbH & Co. KG
bluetooth
In Commercial Distribution

  • 04260482990596 ()
109 2351

  • Dental power tool system handpiece, line-powered
EndoPilot contra-angle for apexlocation full isolated transmission 1:1 with ISO-E standard
Schlumbohm GmbH & Co. KG
1:1
In Commercial Distribution

  • 04260482990091 ()
109 0126

  • Dental power tool system handpiece, line-powered
EndoPilot Motor with ISO-E standard; LED-indicator and Apex-contact
Schlumbohm GmbH & Co. KG
EDP2
In Commercial Distribution

  • 04260482990084 ()
109 0112

  • Dental power tool system handpiece, line-powered
The NovaPort® one cannulas are thin-walled, wire-reinforced PUR femoral cannulas with a cone without wire reinforcement where the cannulas can be clamped. The NovaPort® one cannulas are inserted percutaneously (Seldinger technique) into vessels. All necessary accessories are delivered with the product.
novalung GmbH
NovaPort® one Vascular Access and Introducer Kit
Not in Commercial Distribution

  • 04260058550759 ()

  • Catheter Gauge: 17 French
8800080

  • Cardiopulmonary bypass cannula, femoral
The NovaPort® one cannulas are thin-walled, wire-reinforced PUR femoral cannulas with a cone without wire reinforcement where the cannulas can be clamped. The NovaPort® one cannulas are inserted percutaneously (Seldinger technique) into vessels. All necessary accessories are delivered with the product.
novalung GmbH
NovaPort® one Vascular Access and Introducer Kit
Not in Commercial Distribution

  • 04260058550735 ()

  • Catheter Gauge: 15 French
8800078

  • Cardiopulmonary bypass cannula, femoral
The NovaPort® one cannulas are thin-walled, wire-reinforced PUR femoral cannulas with a cone without wire reinforcement where the cannulas can be clamped. The NovaPort® one cannulas are inserted percutaneously (Seldinger technique) into vessels. All necessary accessories are delivered with the product.
novalung GmbH
NovaPort® one Vascular Access and Introducer Kit
Not in Commercial Distribution

  • 04260058550742 ()

  • Catheter Gauge: 15 French
8800079

  • Cardiopulmonary bypass cannula, femoral
The NovaPort® one cannulas are thin-walled, wire-reinforced PUR femoral cannulas with a cone without wire reinforcement where the cannulas can be clamped. The NovaPort® one cannulas are inserted percutaneously (Seldinger technique) into vessels. All necessary accessories are delivered with the product.
novalung GmbH
NovaPort® one Vascular Access and Introducer Kit
Not in Commercial Distribution

  • 04260058550728 ()

  • Catheter Gauge: 13 French
8800077

  • Cardiopulmonary bypass cannula, femoral
No Description
KaVo Dental GmbH
1.007.5551
In Commercial Distribution

  • EKAV100755510 ()
E25 C

  • Dental power tool system handpiece, line-powered
This is a medical device.
KaVo Dental GmbH
1.007.5550
In Commercial Distribution

  • EKAV100755500 ()
E25 L

  • Dental power tool system handpiece, line-powered
This is a medical device.
KaVo Dental GmbH
1.007.5540
In Commercial Distribution

  • EKAV100755400 ()
E20 L

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.007.5531
In Commercial Distribution

  • EKAV100755310 ()
E15 C

  • Dental power tool system handpiece, line-powered
No Description
KaVo Dental GmbH
1.007.5530
In Commercial Distribution

  • EKAV100755300 ()
E15 L

  • Dental power tool system handpiece, line-powered
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