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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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Flight Latch Type Head Contra Angle Push Button External Spray (For CA Burs 2.35)
Flight Dental Systems
FFB-HEAD
In Commercial Distribution

  • D884FFBHEAD1 ()


  • Dental surgical power tool motorized handpiece/set, pneumatic
An external lead that joins the FLOW COUPLER probe to the FLOW COUPLER Monitor
SYNOVIS MICRO COMPANIES ALLIANCE, INC
GEM1003EXT-FC
In Commercial Distribution

  • 10844735005186 ()
  • 00844735005189 ()
515410000040

  • Electrical-only medical device connection cable, single-use
A custom manufactured solid Bolus Compensators for intensity modulation of external beam radiation therapy.
DECIMAL, INC.
1.0
In Commercial Distribution

  • 00851147007021 ()


  • Radiation therapy beam block material
Custom manufactured solid Range Compensators for intensity modulation of external beam proton radiation therapy.
DECIMAL, INC.
2.8
In Commercial Distribution

  • 00851147007014 ()


  • Radiation therapy beam block material
Cartridge based silicone materials for taking external impressions to aid the construction of prostheses.
TECHNOVENT LIMITED
CoForm Hard Impression Material – 40g
In Commercial Distribution

  • 05060483012476 ()
M518

  • Silicone dental impression material
Cartridge based silicone materials for taking external impressions to aid the construction of prostheses.
TECHNOVENT LIMITED
CoForm Soft Impression Material – 40g
In Commercial Distribution

  • 05060483012452 ()
M517

  • Silicone dental impression material
FIXED CHAIR MOUNT DUO UNIT W/SIDEBOX, EXTERNAL UMBILICAL & EURO CONTROL HEAD, FOREST GREY
Ls Enterprises, Inc.
4987SE-G
In Commercial Distribution

  • D0694987SEG0 ()


  • Dental delivery system
FIXED CHAIR MOUNT DUO UNIT W/SIDEBOX, EXTERNAL UMBILICAL & EURO CONTROL HEAD, DESIGNER FRIENDLY
Ls Enterprises, Inc.
4987SE-C
In Commercial Distribution

  • D0694987SEC0 ()


  • Dental delivery system
FIXED CHAIR MOUNT DR'S UNIT WITHOUT SIDEBOX W/EXTERNAL UMBILICAL & STANDARD IC CONTROL HEAD
Ls Enterprises, Inc.
4485FE
In Commercial Distribution

  • D0694485FE0 ()


  • Dental delivery system
BASIC CUSPIDOR W/ASSISTANT'S INSTRUMENTATION & EXTERNAL UMBILICAL , POST MOUNT, W/WATER REGULATOR & MASTER SHUT-OFF
Ls Enterprises, Inc.
1637FE
In Commercial Distribution

  • D0691637FE0 ()


  • Dental delivery system
BASIC CUSPIDOR W/EXTERNAL UMBILICAL, POST MOUNT, W/WATER REGULATOR & MASTER SHUT-OFF, FOREST GREY
Ls Enterprises, Inc.
1636FE-G
In Commercial Distribution

  • D0691636FEG0 ()


  • Dental delivery system
BASIC CUSPIDOR W/EXTERNAL UMBILICAL, POST MOUNT, W/WATER REGULATOR & MASTER SHUT-OFF, DESIGNER FRIENDLY
Ls Enterprises, Inc.
1636FE-C
In Commercial Distribution

  • D0691636FEC0 ()


  • Dental delivery system
Hermetic™ Plus External CSF Drainage System with Anti-Reflux Valve and Needleless Injection Sites
Integra Lifesciences Corporation
INS8301
In Commercial Distribution

INS8301

  • Ventricular cerebrospinal fluid drainage catheterization kit
  • Lumbar cerebrospinal fluid drainage catheterization kit
MoniTorr™ ICP External CSF Drainage and Monitoring System with Anti-Reflux Valve in Bag
Integra Lifesciences Corporation
INS1100
In Commercial Distribution


  • 500ml drainage bag, 100ml graduated burette, 206cm green striped tubing line
INS1100

  • Ventricular cerebrospinal fluid drainage catheterization kit
  • Lumbar cerebrospinal fluid drainage catheterization kit
Single-Use Z/pH Probe (External Reference), Dual pH (Gastric and Esophageal), Locator Port 6cm
DIVERSATEK HEALTHCARE, INC.
ZAI-BG-44E
In Commercial Distribution

  • 00816734022214 ()
  • B019ZAIBG44E0 ()

  • Catheter Gauge: 6.9 French
ZAI-BG-44E

  • Manometric gastrointestinal motility analysis system
MoniTorr™ ICP External CSF Drainage and Monitoring System with Anti-Reflux Valve in Bag
Integra Lifesciences Corporation
INS1100
In Commercial Distribution

  • 10381780071037 ()
  • M269INS11001 ()

  • 500ml drainage bag, 100ml graduated burette, 206cm green striped tubing line
INS1100

  • Lumbar cerebrospinal fluid drainage catheterization kit
  • Ventricular cerebrospinal fluid drainage catheterization kit
Hermetic™ Plus Hermetic Plus™ External CSF Drainage System with Needleless Injection Sites
Integra Lifesciences Corporation
INS8302
In Commercial Distribution

  • 10381780071006 ()
  • M269INS83021 ()

  • 700ml drainage bag, 75ml burette chamber, 150cm green striped tubing line
INS8302

  • Ventricular cerebrospinal fluid drainage catheterization kit
  • Lumbar cerebrospinal fluid drainage catheterization kit
MoniTorr™ ICP ICP External CSF Drainage and Monitoring System includes In-Line One Way-Valv
Integra Lifesciences Corporation
10102
In Commercial Distribution

  • 10381780070832 ()
  • M269101021 ()

  • 10cm x 26.5cm
10102

  • Ventricular cerebrospinal fluid drainage catheterization kit
  • Lumbar cerebrospinal fluid drainage catheterization kit
MoniTorr™ ICP External CSF Drainage and Monitoring System with Anti-Reflux Valve in Bag
Integra Lifesciences Corporation
SP0236
In Commercial Distribution

  • 10381780072560 ()
  • M269SP02361 ()
SP0236

  • Lumbar cerebrospinal fluid drainage catheterization kit
  • Ventricular cerebrospinal fluid drainage catheterization kit
Hermetic™ Plus External CSF Drainage System with Anti-Reflux Valve and Needleless Injection Site
Integra Lifesciences Corporation
SP0211
In Commercial Distribution

  • 10381780072034 ()
  • M269SP02111 ()
SP0211

  • Ventricular cerebrospinal fluid drainage catheterization kit
  • Lumbar cerebrospinal fluid drainage catheterization kit
Compatible with Southern Implants External Hex implants Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE13002
In Commercial Distribution

  • D800BSFE13002 ()


  • Dental implant suprastructure, temporary, preformed, reusable
Compatible with Southern Implants External Hex implants Consisting of: 1x Screw for impression copings
ZIRKONZAHN SRL
BSFE13001
In Commercial Distribution

  • D800BSFE13001 ()


  • Dental implant suprastructure, temporary, preformed, reusable
CODMAN Lumbar Catheter Kit II (82-1707) with EDS 3 CSF External Drainage System (82-1731)
Cerenovus, Inc.
82-1738
Not in Commercial Distribution

  • 10886704040958 ()
821738

  • Lumbar cerebrospinal fluid drainage catheterization kit
6.0mm External Hex Plastic Straight Locking Implant Abutment Flat GH 4mm Profile Dia: 6.0mm
TITAN IMPLANT INC
T-6PSLIAF-01-4.0
In Commercial Distribution

  • 00842448111944 ()


  • Dental implant suprastructure, temporary, preformed, single-use
5.0mm External Hex Simple Step Abutment Prep Height 7.0mm, Profile Dia: 5.0mm GH 4mm
TITAN IMPLANT INC
T-5ESA7H1-4.0
In Commercial Distribution

  • 00842448111135 ()


  • Dental implant suprastructure, permanent, preformed
5.0mm External Hex Simple Step Abutment Prep Height 7.0mm, Profile Dia: 5.0mm GH 2mm
TITAN IMPLANT INC
T-5ESA7H1-2.0
In Commercial Distribution

  • 00842448111128 ()


  • Dental implant suprastructure, permanent, preformed
5.0mm External Hex Simple Step Abutment Prep Height 5.5mm, Profile Dia: 5.0mm GH 2mm
TITAN IMPLANT INC
T-5ESA5H1-2.0
In Commercial Distribution

  • 00842448111111 ()


  • Dental implant suprastructure, permanent, preformed
5.0mm External Hex Simple Step Abutment Prep Height 4.0mm, Profile Dia: 5.0mm GH 2mm
TITAN IMPLANT INC
T-5ESA4H1-2.0
In Commercial Distribution

  • 00842448111104 ()


  • Dental implant suprastructure, permanent, preformed
4.1mm External Hex Simple Step Abutment 7.0mm Prep Ht Profile Dia:6mm GH 2mm
TITAN IMPLANT INC
T-4ESA7H3-2.0
In Commercial Distribution

  • 00842448110190 ()


  • Dental implant suprastructure, permanent, preformed
4.1mm External Hex Simple Step Abutment 7.0mm Prep Ht Profile Dia:5mm GH 4mm
TITAN IMPLANT INC
T-4ESA7H2-4.0
In Commercial Distribution

  • 00842448110183 ()


  • Dental implant suprastructure, permanent, preformed
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