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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Defibrillator/Pacer Analyzer
FLUKE ELECTRONICS CORPORATION
IMPULSE4K-USA120V
In Commercial Distribution

  • 00850540007133 ()
2247157

  • External defibrillator tester
Defibrillator Analyzer
FLUKE ELECTRONICS CORPORATION
IMPULSE 6000D
In Commercial Distribution

  • 00850540007119 ()
2811928

  • External defibrillator tester
Defibrillator Analyzer, without Transcutaneous Pacemaker Input - private labeled for Gossen Metrawatt
BC GROUP INTERNATIONAL, INC.
DF Base
In Commercial Distribution

  • 00863313000354 ()
M695Q

  • External defibrillator tester
Defibrillator Analyzer, with Transcutaneous Pacemaker Input - private labeled for Gossen Metrawatt
BC GROUP INTERNATIONAL, INC.
DF+
In Commercial Distribution

  • 00863313000347 ()
M695P

  • External defibrillator tester
Defibrillator Analyzer Variable Load, for use with Seculife DF Base and Seculife DF+ - private labeled for Gossen Metrawatt
BC GROUP INTERNATIONAL, INC.
VL
In Commercial Distribution

  • 00863313000330 ()
M695V

  • External defibrillator tester
Defibrillator Analyzer Variable Load, for use with DA-2006 and DA-2006P models.
BC GROUP INTERNATIONAL, INC.
DA-2006-VL
In Commercial Distribution

  • 00863313000323 ()
DA-2006-VL

  • External defibrillator tester
Defibrillator Analyzer, with Transcutaneous Pacemaker Input
BC GROUP INTERNATIONAL, INC.
DA-2006P
In Commercial Distribution

  • 00863313000316 ()
DA-2006P

  • External defibrillator tester
Defibrillator Analyzer, without Transcutaneous Pacemaker Input
BC GROUP INTERNATIONAL, INC.
DA-2006
In Commercial Distribution

  • 00863313000309 ()
DA-2006

  • External defibrillator tester
The DELTA 3300 Defibrillator / Transcutaneous Pacemaker Analyzer is a precision instrument for testing defibrillators and external (Transcutaneous) Pacemakers. It combines the complete testing functions of a Defibrillator Tester, Transcutaneous Pacemaker Analyzer, and 12-Lead ECG / Arrhythmia Simulator into one compact, lightweight, and easy-to-use instrument. The Delta 3300 tests all Defibrillators including AEDs. It measures both monophasic and Bi-Phasic waveforms. It is compact, lightweight and easy to use. The test results can be saved in the internal memory and uploaded to the PC and printed using ProComPrint software (CD included with the unit).
NETECH CORPORATION
DELTA 3300
In Commercial Distribution

  • B3356600 ()
660

  • External defibrillator tester
Delta 3000 is a full function defibrillator analyzer including Transcutaneous Pacemakers. In addition to the capability of testing all bi-polar defibrillators, it tests all Transcutaneous pacers, Atrial and Ventricular pacemakers. Delta 3000 is compact, light weight and easy to use. Among the functions include energy, peak voltage as well as cardio version, 10 lead ECG Arrhythmia waveform. Test results can be easily uploaded to a PC through the serial port.
NETECH CORPORATION
Delta 3000
In Commercial Distribution

  • B3356500 ()
650

  • External defibrillator tester
Phase3 is the first Defibrillator / Pacer Analyzer specifically designed to test Pulsed Multiphasic defibrillators. – tests Monophasic, Biphasic and Pulsed Multiphasic Defibrillators, AEDs and Transcutaneous Pacers – see www.datrend.com for complete information
Datrend Systems Inc
Phase3
In Commercial Distribution

  • B418PHASE380004400 ()
8000-440

  • External defibrillator tester
Freedom Spinal Cord Stimulator System/StimQ Peripheral Nerve Stimulator System Wearable Antenna Assembly/StimQ Wearable Antenna Gear
STIMWAVE TECHNOLOGIES INCORPORATED
PDBT-915-2K
In Commercial Distribution

  • 00818225020822 ()


  • Multiple active implantable device programmer
  • Implantable spinal cord electrical stimulation system programmer
Wearable Antenna Assembly/StimQ Wearable Antenna Gear
STIMWAVE TECHNOLOGIES INCORPORATED
PDBT-915-2K
In Commercial Distribution

  • 00818225020150 ()


  • Implantable spinal cord electrical stimulation system programmer
  • Multiple active implantable device programmer
INSERT, MALE, EXTERNAL, CATHETER, HDPE, DISPOSABLE, BOX of 100 Used to join Uro-Con® “High-Quality” Latex Sheaths and pliable, white-rubber tubing to make Uro-Con® “Texas-Style” male external catheters.
UROCARE PRODUCTS, INC.
6007
In Commercial Distribution

  • 00792293060075 ()

  • Length: 0.5 Inch
  • Outer Diameter: 0.355 Inch
  • Weight: 0.64 Pound
  • Lumen/Inner Diameter: 0.35 Inch
6007

  • Urinary incontinence penis sheath/port, single-use
External USB Drive for archiving of files from the Clinician Programming System laptop.
Second Sight Medical Products, Inc.
014931-001
Not in Commercial Distribution

  • 00856264005455 ()
014931

  • Retinal prosthesis system tester/clinical evaluator
TOSCA 500 Alice DE interface cable. Connecting cable to an external device (PSG).
Radiometer Basel AG
903-342
Not in Commercial Distribution

  • 05700699033420 ()
903-342

  • Transcutaneous blood gas monitoring system
TOSCA 500 Embla MDrive interface cable. Connecting cable to an external device (PSG).
Radiometer Basel AG
903-341
Not in Commercial Distribution

  • 05700699033413 ()
903-341

  • Transcutaneous blood gas monitoring system
TOSCA 500 Alice Int interface cable. Connecting cable to an external device (PSG)
Radiometer Basel AG
903-179
Not in Commercial Distribution

  • 05700699031792 ()
903-179

  • Transcutaneous blood gas monitoring system
ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 50870053000303 ()
  • 00870053000308 ()
1025

  • Chitosan haemostatic agent, professional, non-bioabsorbable
ChitoGauze is intended for temporary external use to stop bleeding in minor wounds.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 50870053000297 ()
  • 00870053000292 ()
1030

  • Chitosan haemostatic agent, professional, non-bioabsorbable
Compatible with: 5.0mm external hex BIOMET 3i implants Overdenture Abutment, Clear Plastic Non-Hexed
DIAMODENT INC
N/A
In Commercial Distribution

  • D907C4010 ()
C401

  • Dental implant suprastructure, permanent, preformed
Flight FG Head for Contra Angle Push Button External Spray (For 1.60 Bur)
Flight Dental Systems
FFB-Y-HEAD
In Commercial Distribution

  • D884FFBYHEAD1 ()


  • Dental surgical power tool motorized handpiece/set, pneumatic
Wylie external carotid clamp, 8 1/4", double angled, atraumatic jaws, ring handle
AMBLER SURGICAL CORP.
17-784
In Commercial Distribution

  • 00190660018344 ()
17-784

  • Vascular clamp, reusable
Durette IV External Laser Eye Shield Replacement Parts, movable metal attachments, 2 temporals
Hayden Medical, Inc.
OP21-550T
In Commercial Distribution

  • 00840319732212 ()
OP21-550T

  • Epiocular radiation shield, reusable
Durette IV External Laser Eye Shield Replacement Parts, movable metal attachments, 2 nasals
Hayden Medical, Inc.
OP21-550N
In Commercial Distribution

  • 00840319732205 ()
OP21-550N

  • Epiocular radiation shield, reusable
For the temporary, external anchoring of sutures and prevention of suture pull through.
PRESERVATION SOLUTIONS INC
RG-3
In Commercial Distribution

  • 10810805000214 ()
  • 00810805000217 ()


  • Suture retention device
ULTRASONIC INSERT CAVITRON 30KHZ PERIO THIN UNIT POWER SETTING: LOW-MED EXTERNAL WATER FLOW
Power Dental U.S.A. Inc.
7604
In Commercial Distribution

  • D9437604 ()
7604

  • Dressing/utility forceps, scissors-like, reusable
  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
ULTRASONIC INSERT CAVITRON 25KHZ PERIO THIN UNIT POWER SETTING : LOW-MED EXTERNAL WATER FLOW
Power Dental U.S.A. Inc.
7602
In Commercial Distribution

  • D9437602 ()
7602

  • Dressing/utility forceps, scissors-like, reusable
  • Ultrasonic dental scaling/debridement system handpiece tip, periodontal
External Hex, autoadvancing tapered Rough Surface Acid Eatched Smart Grip 5.0 X 13mm
ODONTIT S.A.
SGH5013
In Commercial Distribution

  • D914SGH50130 ()
SGH5013

  • Screw endosteal dental implant, two-piece
External Hex, autoadvancing tapered Rough Surface Acid Eatched Smart Grip 5.0 X 11.5mm
ODONTIT S.A.
SGH5011
In Commercial Distribution

  • D914SGH50110 ()
SGH5011

  • Screw endosteal dental implant, two-piece
External Hex, autoadvancing tapered Rough Surface Acid Eatched Smart Grip 5.0 X 10mm
ODONTIT S.A.
SGH5010
In Commercial Distribution

  • D914SGH50100 ()
SGH5010

  • Screw endosteal dental implant, two-piece
External Hex, autoadvancing tapered Rough Surface Acid Eatched Smart Grip 4.0 X 15mm
ODONTIT S.A.
SGH4015
In Commercial Distribution

  • D914SGH40150 ()
SGH4015

  • Screw endosteal dental implant, two-piece
External Hex, autoadvancing tapered Rough Surface Acid Eatched Smart Grip 4.0 X 13mm
ODONTIT S.A.
SGH4013
In Commercial Distribution

  • D914SGH40130 ()
SGH4013

  • Screw endosteal dental implant, two-piece
External Hex, autoadvancing tapered Rough Surface Acid Eatched Smart Grip 4.0 X 11.5mm
ODONTIT S.A.
SGH4011
In Commercial Distribution

  • D914SGH40110 ()
SGH4011

  • Screw endosteal dental implant, two-piece
External Hex, autoadvancing tapered Rough Surface Acid Eatched Smart Grip 4.0 X 10mm
ODONTIT S.A.
SGH4010
In Commercial Distribution

  • D914SGH40100 ()
SGH4010

  • Screw endosteal dental implant, two-piece
External Hex, autoadvancing tapered Rough Surface Acid Eatched Smart Grip 4.0 X 8mm
ODONTIT S.A.
SGH4008
In Commercial Distribution

  • D914SGH40080 ()
SGH4008

  • Screw endosteal dental implant, two-piece
External Hex, autoadvancing tapered Rough Surface Acid Eatched Smart Grip 3,75 X 13mm
ODONTIT S.A.
SGH3013
In Commercial Distribution

  • D914SGH30130 ()
SGH3013

  • Screw endosteal dental implant, two-piece
External Hex, autoadvancing tapered Rough Surface Acid Eatched Smart Grip 3,75 X 11.5mm
ODONTIT S.A.
SGH3011
In Commercial Distribution

  • D914SGH30110 ()
SGH3011

  • Screw endosteal dental implant, two-piece
External Hex, autoadvancing tapered Rough Surface Acid Eatched Smart Grip 3,75 X 10mm
ODONTIT S.A.
SGH3010
In Commercial Distribution

  • D914SGH30100 ()
SGH3010

  • Screw endosteal dental implant, two-piece
Cryogenic Vial Cap - Clear - External thread NON STERILE, RNase DNase-free, PP, 50/500
Corning Incorporated
431337
In Commercial Distribution

  • H1084313373 ()
  • H1084313371 ()
  • H1084313370 ()
431337

  • General specimen container IVD, no additive/medium
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