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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Replacement Slide with Markers, 150cm
Nucletron B.V.
111275P01-03
In Commercial Distribution

  • 08717213015760 ()
  • 08717213039469 ()


  • Remote-afterloading brachytherapy system
SPCR Adapter Set 6F Cath.
Nucletron B.V.
137043-00
In Commercial Distribution

  • 08717213038912 ()
  • 08717213039155 ()


  • Remote-afterloading brachytherapy system
SPCR Adapter Set 5F Cath.
Nucletron B.V.
137042-00
In Commercial Distribution

  • 08717213038905 ()
  • 08717213039148 ()


  • Remote-afterloading brachytherapy system
SPCR ADAPTER SET 5F/6F CATH TT
Nucletron B.V.
137041-00
In Commercial Distribution

  • 08717213038899 ()
  • 08717213039131 ()


  • Remote-afterloading brachytherapy system
SPCR ADAPTER SET GYN TI TT
Nucletron B.V.
137040-00
In Commercial Distribution

  • 08717213038882 ()
  • 08717213039124 ()


  • Remote-afterloading brachytherapy system
Source Position Simulator with Markers Flexitron
Nucletron B.V.
138203-00
In Commercial Distribution

  • 08717213034044 ()


  • Remote-afterloading brachytherapy system
Source Position Simulator for Flexitron With X-Ray Markers
Nucletron B.V.
138202-00
In Commercial Distribution

  • 08717213034037 ()


  • Remote-afterloading brachytherapy system
Source Position Simulator Flexitron
Nucletron B.V.
138201-00
In Commercial Distribution

  • 08717213034013 ()


  • Remote-afterloading brachytherapy system
Source Position Simulator for Flexitron WithDummy Source Cable
Nucletron B.V.
138200-00
In Commercial Distribution

  • 08717213034006 ()


  • Remote-afterloading brachytherapy system
Source Position Simulator (with Markers) for microSelectron
Nucletron B.V.
111096-01
In Commercial Distribution

  • 08717213033993 ()


  • Remote-afterloading brachytherapy system
Source Position Simulator with Markers for microSelectron
Nucletron B.V.
111097-01
In Commercial Distribution

  • 08717213033986 ()


  • Remote-afterloading brachytherapy system
microselectron Source Position Check Ruler
Nucletron B.V.
096035-04
In Commercial Distribution

  • 08717213013117 ()
  • 08717213052192 ()


  • Remote-afterloading brachytherapy system
No Description
VARIAN MEDICAL SYSTEMS, INC.
1.1
In Commercial Distribution

  • 00816389028197 ()


  • Remote-afterloading brachytherapy system
No Description
Varian Medical Systems Deutschland GmbH
GM84000560
In Commercial Distribution

  • 00816389027329 ()
GM84000560

  • Remote-afterloading brachytherapy system
No Description
Varian Medical Systems Deutschland GmbH
GM84000510
In Commercial Distribution

  • 00816389027312 ()
GM84000510

  • Remote-afterloading brachytherapy system
No Description
Raysearch Laboratories AB (Publ)
7
In Commercial Distribution

  • 07350002010068 ()


  • Radiation therapy software
PACSCore VNA archive with remote, remote backup, and optional local repositories, and ConnectWeb on remote archive
Radius
7
In Commercial Distribution

  • B295VNA70 ()


  • Radiological PACS software
Cutaneous Electrode Garment
AXIOBIONICS
7
In Commercial Distribution

  • B3677370 ()
73

  • Transcutaneous electrical stimulation electrode, single-use
Cutaneous Electrode Garment
AXIOBIONICS
7
Not in Commercial Distribution

  • B3676970 ()
69

  • Transcutaneous electrical stimulation electrode, single-use
7" Alligator Rongeur
SIGNAL MEDICAL CORPORATION
7"
In Commercial Distribution

  • B046BIO110420 ()
BIO-1-1042

  • Orthopaedic joint/limb rongeur
FRESH WHOLE BLOOD DONOR SET Constricting Band (18”x1”) 1 ea Alcohol Pads 2 ea Gauze Sponge (4”x4”) 2 ea Chlorhexidine Swab 1 ea Blood Tube- Lavender Top 4 ea 5.5” Kelly Clamp 1 ea Blood Tube- Red Top 2 ea Nylon Cord (10”) 1 ea Blood Collection Needle 21gx1.25" 1 ea Beaded Cable Tie 1 ea Surgical Tape 1 ea Permanent Marker 1 ea Clear IV Dressing 1 ea ASBP 572 1 ea ABO/Rh Screen (EldonCard) 1 ea Blood Bag Label 1 ea Blood Collection Bag 1 ea Instructions for Use 1 ea Gloves (Pair) 1 ea
Safeguard US Operating, LLC
7
Not in Commercial Distribution

  • M68980801D070 ()
80-801-D

  • Blood donor set, single-pack
No Description
mediCAD Hectec GmbH
7
In Commercial Distribution

  • 04260489720110 ()


  • Orthopaedic/craniofacial implantation planning software
MANI CARBIDE BURS
MANI, INC.
7
In Commercial Distribution

  • 74546951534386 ()
  • 04546951534387 ()


  • Carbide dental bur, reusable
The BougieCap is for dilation of strictures in the upper gastrointestinal tract • the transparent cap allows direct visual control during the dilation • the tension on the tissue is visible while passing the stricture, thereby avoiding overstretching • reduced procedure time due to less intrument change • evaluation can be done directly after the dilation thanks to the attached transparent cap • two lateral holes for air insufflation and suction • one centered hole for the insertion of a guide wire
Ovesco Endoscopy AG
7
Not in Commercial Distribution

  • 04260206310792 ()
  • 04260206310808 ()

  • Outer Diameter: 7.1 Millimeter
  • Length: 14.7 Millimeter
  • for endoscopes with diameter 5.5 - 6 mm
  • mounting depht of the cap: 5 mm
400.31.01

  • Endoscopic gastrointestinal stenosis dilator
No Description
Ad-Tech Medical Instrument Corporation
7
In Commercial Distribution

  • 00841823109682 ()
BF09R-SP21X-0CC

  • Depth electrode
The PureWay® Sharps Collector container is blow molded with High Density Polyethylene plastic. The containers are identical except for capacity. The device has a circular opening at the top with an insert to prevent hand access and items from falling out. The insert is made of Low Density Polyethylene plastic, is also circular limiting the opening to 1.25 inches. The opening allows for a vertical sharps drop. Once the PureWay® Sharps Collector container is full, the cap is placed on top of the opening and screwed close for a tight seal. The containers are designed to contain and hold sharps such as angio-caths, blood needles, lancets, cap needles, and various sized syringes. The shape of the container will be rectangular and the only access to the container is through the screw top opening or aperture. In summary, all PureWay® Sharps Collector containers are blow molded using High Density Polyethylene plastic, non-sterile, disposable, sharps containers (infectious waste container). All the devices allow for onehanded disposal of sharps and offer a means of closure. 1.2 gallon twin pack sharps disposal ship back system (Includes two 1.2 gallon sharps container, box, bag, zip tie).
PUREWAY COMPLIANCE
7
In Commercial Distribution

  • 10853022008045 ()
  • 00853022008048 ()

  • Total Volume: 1.2 Gallon
40021

  • Sharps container
MAC 7
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
7
In Commercial Distribution

  • 00840682144322 ()
2109091-001

  • Electrocardiograph, professional, multichannel
ProOcular Daily Disposable Contact Lens Power -7
CARLSBAD TECHNOLOGY INC.
-7
Not in Commercial Distribution

  • 40816816880594 ()
  • 30816816880597 ()
  • 10816816880593 ()
  • 00816816880596 ()


  • Soft corrective contact lens, daily-disposable
Implantable Pulse Generator
ST. JUDE MEDICAL, INC.
7
In Commercial Distribution

  • 05415067020277 ()
6663

  • Deep brain electrical stimulation system
Implantable Pulse Generator
ST. JUDE MEDICAL, INC.
7
In Commercial Distribution

  • 05415067020239 ()
3663

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable
No Description
SWORD HEALTH, S.A.
7
In Commercial Distribution

  • 05065013876030 ()
  • 05065013876023 ()


  • Pelvic floor muscle exerciser
Implantable Pulse Generator
ST. JUDE MEDICAL, INC.
7
In Commercial Distribution

  • 05415067030023 ()
6662

  • Deep brain electrical stimulation system
TIDI Positioning Aid Kits Kit, Various Sizes 4 per Set
TIDI PRODUCTS, LLC
7
Not in Commercial Distribution

  • 00618125168224 ()


  • Multifunction body cushion
The AMADEO system is intended for robot-supported finger-hand therapy of patients with neurological damage to the central nervous system, caused by typical indications such as stroke or traumatic brain injury.
tyromotion GmbH
7
In Commercial Distribution

  • 09120077180014 ()


  • Virtual-display rehabilitation system, powered-support, upper-limb
7" Alligator Rongeur
MEDISURGE LLC
7"
In Commercial Distribution

  • G611BIO110420 ()
BIO-1-1042

  • Orthopaedic joint/limb rongeur
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
Ulab Systems, Inc.
7
In Commercial Distribution

  • 00860002380087 ()


  • Dental milling system, CAD/CAM, laboratory
Powdered Sterile Latex Surgical Gloves
Beijing Reagent Latex Products Factory
7
In Commercial Distribution

  • 16936610210267 ()
  • 06936610210260 ()
  • 26936610210264 ()


  • Hevea-latex surgical glove, powdered
Powder free Sterile Latex Surgical Gloves
Beijing Reagent Latex Products Factory
7
In Commercial Distribution

  • 16936610210175 ()
  • 06936610210178 ()
  • 26936610210172 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial
Porti
TMSi
7
In Commercial Distribution

  • 08719481170011 ()


  • Multiple physiological signal amplifier
SE CUTTING INSTRUMENT NO. 7
NORDENT MANUFACTURING INC
7
In Commercial Distribution

  • 00840018633704 ()


  • Margin finishing dental file/rasp, reusable
No Description
SORIN GROUP ITALIA SRL
7
In Commercial Distribution

  • 38033178113213 ()
  • 08033178113212 ()


  • Extracorporeal membrane oxygenator
No Description
ASPYRA, LLC
7
In Commercial Distribution

  • B433AN0 ()


  • Radiological PACS software
The QUICKIE® 7 Series redefines ultra lightweight wheelchair technology for the active user. Its personalized ergonomics, premium materials, and open back design offer you ultimate freedom of movement. Where will you go?
SUNRISE MEDICAL (US) LLC
7
In Commercial Distribution

  • 00016958052367 ()
EIPW11

  • Wheelchair, occupant-driven, rear-wheels-operated, non-collapsible
SGP (acronym for Sistema de Gestion del Plasma or Plasma Management System) is an application designed to manage the logistics of plasma stored in a central warehouse of a plasma manufacturing organization or a fractionation facility. This includes all activities from receipt of plasma to fractionation, as it relates to storage and control of the plasma units.
BIOMAT USA, INC.
7
In Commercial Distribution

  • 00817955020010 ()


  • Blood bank information system application software
Sample Collection Kit
Biodesix, Inc.
7
In Commercial Distribution

  • G292560 ()
56

  • Blood collection set, invasive
Sample Collection Kit
Biodesix, Inc.
7
Not in Commercial Distribution

  • G292550 ()
55

  • Blood collection set, invasive
Cardiovascular Image and Information Management Solution (CVIS)
Philips Medical Systems Nederland B.V.
7
In Commercial Distribution

  • 00884838115378 ()
830089

  • Radiology picture archiving and communication system workstation
KIT, SMALL. Includes: 128 – WEDGE, 3” x 10” x 10” (00810050240819), 129 – WEDGE, 4.63" x 10" x 10" (00810050240314), 130 – WEDGE, 10" x 10" x 10" (00810050240826), 140 – WEDGE, 6" x 10" x 10" (00810050240369)
DOMICO MED-DEVICE, LLC
7
Not in Commercial Distribution

  • 00810050245357 ()


  • Multifunction body cushion
  • Radiological general body-part positioner
Powder-free textured; The packages of proposed device including immediate package, middle box package and outer carton package. Immediate package quantity: 1 pair Middle box package quantity: 50 pairs Outer carton package quantity: 400 pairs
Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.
7
In Commercial Distribution

  • 16972267280116 ()
  • 06972267280119 ()
  • 26972267280113 ()


  • Hevea-latex surgical glove, non-powdered, non-antimicrobial
No Description
Chemoment Materials Co., Ltd.
7
In Commercial Distribution

  • 06976009587771 ()


  • Silicone dental impression material
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