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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To wash the sample flow path.
Diamond Diagnostics Inc.
CD-104226D
In Commercial Distribution

  • 00811403011834 ()
  • 00811403013029 ()


  • Wash/cleaning solution IVD, automated/semi-automated system
The intraoral tips are attached to the mixing tips to allow the intraoral application of the correction material directly from the cartridge. Used in dentistry.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
02105
In Commercial Distribution

  • EBIB021051 ()
02105

  • Dental material mixing nozzle
The intraoral tips are attached to the mixing tips to allow the intraoral application of the correction material directly from the cartridge. Used in dentistry.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
02100
In Commercial Distribution

  • EBIB021001 ()
02100

  • Dental material mixing nozzle
The intraoral tips are attached to the mixing tips to allow the intraoral application of the correction material directly from the cartridge. Used in dentistry.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
01965
In Commercial Distribution

  • EBIB019651 ()
01965

  • Dental material mixing nozzle
The intraoral tips are attached to the mixing tips to allow the intraoral application of the correction material directly from the cartridge. Used in dentistry.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
01960
In Commercial Distribution

  • EBIB019601 ()
01960

  • Dental material mixing nozzle
The intraoral tips are attached to the mixing tips to allow the intraoral application of the correction material directly from the cartridge. Used in dentistry.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
01800
In Commercial Distribution

  • EBIB018001 ()
01800

  • Dental material mixing nozzle
The intraoral tips are attached to the mixing tips to allow the intraoral application of the correction material directly from the cartridge. Used in dentistry.
bisico Bielefelder Dentalsilicone GmbH & Co. KG
01790
In Commercial Distribution

  • EBIB017901 ()
01790

  • Dental material mixing nozzle
Sagittal Rod is a part of the Tibial Alignment guide, and is connected to the Sagittal Connector to provide parallel alignment to the tibia in the sagittal plane.
Ascension Orthopedics, Inc.
10204029
In Commercial Distribution

  • M268102040291 ()
  • 10381780240389 ()

  • 12in L x .125in diameter
10204029

  • Joint prosthesis implantation kit, reusable
Integra® External Fixation System The wire tensioner is used to apply tension to the wires after they are run through the bone and attached to the ring.
Ascension Orthopedics, Inc.
12225300
In Commercial Distribution

  • M269122253001 ()
  • 10381780248149 ()

  • .004 in opening
12225300

  • External orthopaedic fixation system, reusable
Intended to standardize OR Cameras to allow for the use of the OR Camera Cover
ASPEN SURGICAL PRODUCTS, INC.
LT-C02
In Commercial Distribution

  • 00840113219971 ()
  • 00840113219964 ()


  • Medical equipment handle cover, single-use
Intended to standardize OR Cameras to allow for the use of the OR Camera Cover
ASPEN SURGICAL PRODUCTS, INC.
LT-C01
In Commercial Distribution

  • 00840113219919 ()
  • 00840113219926 ()


  • Medical equipment handle cover, single-use
Instrument used to mark or guide the implant or another instrument to the surgical site.
AJU PHARM. CO., LTD.
Fixone.I.S-D/G300
In Commercial Distribution

  • 08800039100663 ()


  • Surgical drill guide, reusable
Medical device cart to hold the necessary devices to accompany the patient in intra-hospital movements.
CGC Technologies Inc
MED-FB4EP2I4T
In Commercial Distribution

  • 00628678604056 ()
  • 10628678604053 ()


  • Electromechanical device/system transport trolley
This curing light is to provide photosensitive resins the activation required to cure the material.
Flight Dental Systems
X-CURE
In Commercial Distribution

  • D884XCURE0 ()
FLIGHT X-CURE CURING LIGHT

  • Dental/surgical polymerization lamp
The Child Sacral Rest Pad attaches to orthopedic table to support the patient's sacral area.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995182311 ()
BF826

  • Operating table mattress, basic
The 2-inch Wedge Shape Sacral attaches to orthopedic table to support the patient's sacral area.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995171407 ()
BF825

  • Operating table mattress, basic
The T-Shape Sacral Rest Pad attaches to orthopedic table to support the patient's sacral area.
STERIS CORPORATION
Table Pad
In Commercial Distribution

  • 00724995171391 ()
BF824

  • Operating table mattress, basic
The Non-contact Infrared Thermometer uses infrared sensor (thermopile) to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object and the infrared sensor can recognize it to transfer to the proper electronic signal. The electronic signal can be processed in the subject device to convert to the temperature reading. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits.
DEOCCO LLC
OCCOscan
Not in Commercial Distribution

  • 00863101000313 ()


  • Infrared patient thermometer, skin
The staple impactor is used to impact the staples to ensure that thay are flush with the bone surface.
NEWDEAL
119309ND
In Commercial Distribution

  • M248119309ND1 ()
  • 10381780045915 ()


  • Orthopaedic implant impactor, reusable
The vibrating drive system "Vibrasat Pro" is used to oscillate cannulas to support the hand movement of the user.
Möller Medical GmbH
00003922
In Commercial Distribution

  • 04260277178062 ()
00003920

  • Liposuction system
The vibrating drive system 'Vibrasat Pro' is used to oscillate cannulas to support the hand movement of the user.
Möller Medical GmbH
00003921
In Commercial Distribution

  • 04260277178055 ()
00003920

  • Liposuction system
Suture Fisher Hip - Suture Holder 45° to the Left
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Suture Holder 45° to the Left
In Commercial Distribution

  • 07899258662626 ()
361-60

  • Suturing unit, single-use
Suture Fisher Hip - Suture Holder 45° to the Right
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Suture Holder 45° to the Right
In Commercial Distribution

  • 07899258662619 ()
361-50

  • Suturing unit, single-use
Suture Fisher - Suture Holder 45° to the Left
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Suture Holder 45° to the Left
In Commercial Distribution

  • 07899258662596 ()
361-30

  • Suturing unit, single-use
Suture Fisher - Suture Holder 45° to the Right
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Suture Holder 45° to the Right
In Commercial Distribution

  • 07899258662589 ()
361-20

  • Suturing unit, single-use
The Cross-Seal Accessories (Cross-Seal Knot Tyer, Cross-Seal Knot Pusher, and Cross-Seal Suture Trimmer) are designed to tie the knots, position the knot to the top of the arteriotomy, and to trim the trailing limbs of the suture, respectively.
MEDEON BIODESIGN, INC.
002
In Commercial Distribution

  • 04719872920380 ()
  • 04719872920397 ()
  • 04719872920403 ()
002

  • Polyolefin/fluoropolymer suture, monofilament
The MICRO Elite Snare is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.
Vascular Solutions, Inc.
8302
Not in Commercial Distribution

  • M20683020 ()

  • Length: 180 Centimeter
  • 7 mm Snare Loop
  • Outer Diameter: 0.014 Inch


  • Intravascular extraction catheter-snare
The MICRO Elite Snare is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the coronary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.
Vascular Solutions, Inc.
8301
Not in Commercial Distribution

  • M20683010 ()

  • Length: 180 Centimeter
  • 4 mm Snare Loop
  • Outer Diameter: 0.014 Inch


  • Intravascular extraction catheter-snare
Rejoyn (also known as CT-152) is a digital therapeutic smartphone application (app) for the treatment of Major Depressive Disorder (MDD) symptoms. Rejoyn is a prescription smartphone app-based digital therapeutic administered to a user via the user’s smartphone device (running Apple iPhone operating system [iOS®] or Android™ operating system [OS]), which delivers a proprietary interactive cognitive emotional and behavioral therapeutic intervention. The core components of Rejoyn are the Emotional Faces Memory Task (EFMT) exercises, brief cognitive behavioral therapy (CBT)-based lessons to learn and apply key therapeutic skills, and short message service (SMS) text messaging to reinforce CBT-based lesson content and to encourage engagement with the app. It is intended for the treatment of MDD symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older. It is intended to reduce MDD symptoms. Rejoyn is designed for use as an adjunct to clinician-managed outpatient care over a period of 6 weeks for the treatment of MDD symptoms, followed by a 4-week extension period where CBT-based lesson content will be accessible but no new therapeutic content or EFMT exercises will be available. Rejoyn is not intended to be used as a stand-alone therapy or as a substitution for the patient’s clinician prescribed medications.
Otsuka Pharmaceutical Development & Commercialization, Inc.
CT-152
In Commercial Distribution

  • 00857335005121 ()
  • 57335-0005-12 ()
57335000512

  • Mental health/function therapeutic software, screen-viewed
Tool to be added to implant instrument to increase the length for surgery.
STERNGOLD DENTAL LLC
905280
In Commercial Distribution

  • 00841549118067 ()


  • Surgical screwdriver, reusable
The VX120+ is a multi-function diagnostic device combining corneal topographer, retro-illuminator, and pachymeter, indicated for: Measuring the refraction of the eye giving both lower and higher order aberrations Measuring the shape of the cornea Retro-illumination imaging of the eye Measuring the intraocular pressure without contacting the eye for glaucoma evaluation. Photographing the eye and taking images of the eye to evaluate the thickness of the cornea.
LUNEAU TECHNOLOGY OPERATIONS
VX110
In Commercial Distribution

  • 03664188000060 ()


  • Automated ophthalmic refractometer
  • Pupillometer, electrically-powered
Cable connecting the Raypilot Power box to the Raypilot Receiver
Micropos Medical AB (Publ)
1
In Commercial Distribution

  • 07350007956026 ()
6002

  • Radiation therapy invasive marker lesion localization system
The EsoSure Esophageal Retractor is intended to move the esophagus.
NORTH EAST SCIENTIFIC INC
100001
In Commercial Distribution

  • B2271000010 ()

  • Outer Diameter: 0.052 Inch
100001

  • Intraluminal oesophageal retractor
Inject into the knee to relieve the pain from osteoarthritis.
ACRE PHARMA LIMITED
NA
In Commercial Distribution

  • 05060604130034 ()


  • Synovial fluid supplementation medium
Injected into the knee to relieve the pain from osteoarthritis.
ACRE PHARMA LIMITED
NA
In Commercial Distribution

  • 05060604130027 ()


  • Synovial fluid supplementation medium
Injected into the knee to relieve the pain from osteoarthritis.
ACRE PHARMA LIMITED
NA
In Commercial Distribution

  • 05060604130003 ()


  • Synovial fluid supplementation medium
The NeuroStar Headrest can be adjusted to the patient's comfort.
NEURONETICS, INC.
81-72026-000
In Commercial Distribution

  • 00850005944348 ()


  • Magnetic neural stimulation system
The ATLAS Workstation Monitor connects to the ATLAS Workstation (31-0004-0000).
NEURALYNX, INC.
ATLAS Workstation Monitor
In Commercial Distribution

  • 00850011306932 ()
31-0000-0002

  • Electroencephalographic monitoring system
The EsoSure Esophageal Retractor is intended to move the esophagus.
NORTH EAST SCIENTIFIC INC
100001
In Commercial Distribution


  • Outer Diameter: 0.109 Inch
100001

  • Intraluminal oesophageal retractor
Cannula to take the fat off the canister for lipotransfer.
AESTHETIC GROUP
3,0mm x 30 cm - 1-hole
In Commercial Distribution

  • 03760037733414 ()
  • 03760037733421 ()
CPOE3300

  • Tissue injection cannula
Cannula to take the fat off the canister for lipotransfer.
AESTHETIC GROUP
3,0mm x 15,5 cm - 1-hole
In Commercial Distribution

  • 03760037733353 ()
  • 03760037733360 ()
CPOE3155

  • Tissue injection cannula
The Disposable Handle Assembly is a sub-assembly of the View Medical SurgiLight. The Disposable Handle Assembly attaches to the SurgiLight and is essential to the overall functionality of the surgical light. The dual purpose handle gives the user the ability to focus the light by rotating the handle and serves as a layer of protection for the light-emitting diode (LED) housing. The medical cover sleeve is extended over the SurgiLight to provide a sterile barrier to the flexible shaft.
BihlerMed, L.L.C.
2816-01-0002
In Commercial Distribution

  • 20865082000171 ()
  • 10865082000174 ()


  • Medical equipment handle cover, single-use
2.2 mm Foreign Body Forceps with 1x2 Teeth
Surgical Direct, Inc.
SD611159
In Commercial Distribution

  • B382SD6111590 ()
SD611159

  • Flexible endoscopic biopsy forceps, reusable
5fr 40cm Foreign Body Flexible Grasper, Double Action
Surgical Direct, Inc.
SD56540-52
In Commercial Distribution

  • B382SD56540520 ()
SD56540-52

  • Flexible endoscopic biopsy forceps, reusable
3fr, 92cm Foreign Body Grasper, Double Action, Flexible
Surgical Direct, Inc.
SD56392-50
In Commercial Distribution

  • B382SD56392500 ()
SD56392-50

  • Flexible endoscopic biopsy forceps, reusable
5fr Foreign Body Forceps, Flexible, 400mm, Double Action
Surgical Direct, Inc.
SD41269
In Commercial Distribution

  • B382SD412690 ()
SD41269

  • Flexible endoscopic biopsy forceps, reusable
7fr Flexible Foreign Body Forceps, Double Action, 38cm
Surgical Direct, Inc.
SD41259s
In Commercial Distribution

  • B382SD41259S0 ()

  • Length: 38 Centimeter
  • Catheter Gauge: 7 French
SD41259s

  • Endoscope sheath, reusable
3FR, 28CM, FLEXIBLE, FOREIGN BODY GRASPER, DOUBLE ACTION
ELMED INCORPORATED
31328-51
In Commercial Distribution

  • 00842180166288 ()
31328-51

  • Flexible endoscopic tissue manipulation forceps, reusable
3FR, 28CM, FLEXIBLE, FOREIGN BODY GRASPER, DOUBLE ACTION
ELMED INCORPORATED
ST3132851
In Commercial Distribution

  • 00198506002083 ()
ST3132851

  • Flexible endoscopic tissue manipulation forceps, reusable
5FR, 55CM, FLEXIBLE FOREIGN BODY GRASPER, DOUBLE ACTION
ELMED INCORPORATED
31555-50
In Commercial Distribution

  • 00198506074677 ()
31555-50

  • Flexible endoscopic tissue manipulation forceps, reusable
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