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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No Description
BIOGENEX LABORATORIES
AM702-5M
In Commercial Distribution

  • 00810119671790 ()

  • Total Volume: 6 Milliliter
AM702-5M

  • CD7 cell marker IVD, antibody
No Description
BIOGENEX LABORATORIES
MU702-UC
In Commercial Distribution

  • 00810119675699 ()

  • Total Volume: 1 Milliliter
MU702-UC

  • CD7 cell marker IVD, antibody
Hermesh 7 cm 8x15 is a rectangular ultra-light macroporous mesh knitted with Polypropylene monofilament, indicated for both open and laparoscopic hernia repair
HERNIAMESH SRL
H70815
Not in Commercial Distribution

  • 58032919891322 ()
  • 18032919891324 ()


  • Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
PVP 7%, 6 x 0,5 ml
Origio A/S
ART-4005-A
In Commercial Distribution

  • 20888937818820 ()
  • 00888937818840 ()


  • IVF medium
No Description
Sonova AG
7.0
In Commercial Distribution

  • 07613389759259 ()
088-0022-00070

  • Audiometric/hearing device software
No Description
Sonova AG
7.2
In Commercial Distribution

  • 07613389779271 ()
088-0022-00072

  • Audiometric/hearing device software
No Description
Sonova AG
7.1
In Commercial Distribution

  • 07613389779257 ()
088-0022-00071

  • Audiometric/hearing device software
The LiquoGuard 7 CSF Drainage System consists of a pump and a corresponding disposable drainage tube set, including two pressure sensors. The dynamic range of this system is from -75 mmHg to +100 mmHg. The drainage tube set is inserted into the pump, connected to the intrathecal drainage catheter (not part of the product) via a 3- way stopcock and the LiquoGuard 7 device via cable connector. The device continuously measures the pressure of CSF due to the fluid column inside the tube and operates the peristaltic pump of LiquoGuard 7 whenever the current patient’s CSF pressure is higher than a preselected target pressure. Thus the LiquoGuard 7 combines CSF drainage and intracranial pressure (ICP) monitoring like the predicate device, the LiquoGuard CSF System, with integrated alarm and documentation/data logging functions, improving safety, simplifying the handling and enhancing patient’s mobility.
Möller Medical GmbH
00003500
In Commercial Distribution

  • 04260277175788 ()


  • Cerebrospinal fluid pressure regulation system control unit/pump
No Description
Axiodent Inc.
21004 Economy Pack
In Commercial Distribution

  • D161210040 ()


  • Dental acrylic resin kit
No Description
Axiodent Inc.
21003 Intro Pack
In Commercial Distribution

  • D161210030 ()


  • Dental acrylic resin kit
No Description
Visage Imaging GmbH
7.1.18
In Commercial Distribution

  • 04251332910086 ()


  • Radiological PACS software
No Description
Visage Imaging GmbH
7.1.17
In Commercial Distribution

  • 04251332910079 ()


  • Radiological PACS software
No Description
Visage Imaging GmbH
7.1.16
In Commercial Distribution

  • 04251332910062 ()


  • Radiological PACS software
No Description
Visage Imaging GmbH
7.1.15
In Commercial Distribution

  • 04251332910055 ()


  • Radiological PACS software
No Description
Visage Imaging GmbH
7.1.14
In Commercial Distribution

  • 04251332910048 ()


  • Radiological PACS software
No Description
Visage Imaging GmbH
7.1.12
In Commercial Distribution

  • 04251332910031 ()


  • Radiological PACS software
No Description
Visage Imaging GmbH
7.1.11
In Commercial Distribution

  • 04251332910024 ()


  • Radiological PACS software
No Description
Visage Imaging GmbH
7.1.10
In Commercial Distribution

  • 04251332910017 ()


  • Radiological PACS software
No Description
Visage Imaging GmbH
7.1.9
In Commercial Distribution

  • 04251332910000 ()


  • Radiological PACS software
No Description
DATEX-OHMEDA INC
VAP SEV 8% QUIK-FIL EN
In Commercial Distribution

  • 00840682111751 ()


  • Sevoflurane anaesthesia vaporizer
No Description
DATEX-OHMEDA INC
VAP SEV 8% EASY-FIL EN B1
In Commercial Distribution

  • 00840682111744 ()


  • Sevoflurane anaesthesia vaporizer
No Description
DATEX-OHMEDA INC
VAP SEV 8% EASY-FIL EN A1
In Commercial Distribution

  • 00840682111614 ()


  • Sevoflurane anaesthesia vaporizer
No Description
DATEX-OHMEDA INC
VAP SEV 8% EASY-FIL ES LATIN AMERICA
In Commercial Distribution

  • 00840682111508 ()


  • Sevoflurane anaesthesia vaporizer
No Description
DATEX-OHMEDA INC
VAP SEV 8% EASY-FIL EN P1
In Commercial Distribution

  • 00840682111454 ()


  • Sevoflurane anaesthesia vaporizer
No Description
DATEX-OHMEDA INC
VAP ISO 5% EASY-FIL ES LATIN AMERICA
In Commercial Distribution

  • 00840682111393 ()


  • Isoflurane anaesthesia vaporizer
No Description
DATEX-OHMEDA INC
VAP HAL 5% EASY-FIL ES LATIN AMERICA
In Commercial Distribution

  • 00840682111324 ()


  • Halothane anaesthesia vaporizer
No Description
DATEX-OHMEDA INC
VAP SEV 8% EASY-FIL EN
In Commercial Distribution

  • 00840682111317 ()


  • Sevoflurane anaesthesia vaporizer
No Description
DATEX-OHMEDA INC
VAP ISO 5% EASY-FIL EN
In Commercial Distribution

  • 00840682111300 ()


  • Isoflurane anaesthesia vaporizer
No Description
DATEX-OHMEDA INC
VAP HAL 5% EASY-FIL EN
In Commercial Distribution

  • 00840682111003 ()


  • Halothane anaesthesia vaporizer
HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS
STERILMED, INC.
HARH45R
Not in Commercial Distribution

  • 10888551045278 ()
HARH45R

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed
HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS
STERILMED, INC.
HARH36R
Not in Commercial Distribution

  • 10888551045247 ()
HARH36R

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed
HARMONIC ACE+7 SHEARS WITH ADVANCED HEMOSTASIS
STERILMED, INC.
HARH23R
Not in Commercial Distribution

  • 10888551045230 ()
HARH23R

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed
No Description
XIROS LTD
102-1102
In Commercial Distribution

  • 05060267132567 ()
102-1102

  • Polyester suture, non-bioabsorbable, multifilament
Right Eargo 7 Hearing Device
Eargo, Inc.
99-0158-001
In Commercial Distribution

  • 00850010429427 ()


  • Air-conduction hearing aid, in-the-ear
Left Eargo 7 Hearing Device
Eargo, Inc.
99-0157-001
In Commercial Distribution

  • 00850010429410 ()


  • Air-conduction hearing aid, in-the-ear
Eargo 7 System
Eargo, Inc.
99-0156-001
In Commercial Distribution

  • 00850010429403 ()


  • Air-conduction hearing aid, in-the-ear
No Description
Zimmer MedizinSysteme GmbH
7375
In Commercial Distribution

  • 04053815087229 ()
7375

  • Localized cutaneous/musculoskeletal cryotherapy unit
No Description
Zimmer MedizinSysteme GmbH
7370
In Commercial Distribution

  • 04053815080848 ()
7370

  • Localized cutaneous/musculoskeletal cryotherapy unit
The SNAP Model 7 is a 6 channel data recorder that records respiratory and oximetry data. A canula houses a pressure sensor that records the respiratory air flow and respiratory sounds. An oximeter is integrated into the device and records oxygen saturation and pulse rate. A respiratory effort belt records respiratory effort and optionally can record body position.
SNAP DIAGNOSTICS
7-10000
In Commercial Distribution

  • B577710000 ()


  • Polysomnograph
No Description
Zimmer, Inc.
SSI005398
In Commercial Distribution

  • 00889024583146 ()

  • 7
SSI005398

  • Orthopaedic prosthesis implantation positioning instrument, reusable
The Mphi 7 is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improving blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It consists of a control unit which may be mounted on a mobile trolley and one or more connected applicator to delivery of visible/infrared laser light energy.
ASA SRL
F9000258
In Commercial Distribution

  • 08033765391207 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
Hand held Doppler
KOVEN TECHNOLOGY, INC.
BiDop 7
In Commercial Distribution

  • 00894912002159 ()
BiDop 7

  • Noninvasive vascular ultrasound system
InTENSity 7 Digital TENS Device with Accessories
COMPASS HEALTH BRANDS CORP.
DI0007
In Commercial Distribution

  • 80092237623431 ()
  • 00092237623435 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Rigid Gas Permeable Contact Lens
Bausch & Lomb Incorporated
satafocon A
In Commercial Distribution

  • 00785811435769 ()
Boston 7

  • Rigid-gas-permeable corrective contact lens, daily-wear
Reusable Generator
Covidien LP
SCG7AB
In Commercial Distribution

  • 10884521794825 ()


  • Soft-tissue ultrasonic surgical system
Reusable Generator
Covidien LP
SCG7AA
In Commercial Distribution

  • 10884521794818 ()


  • Soft-tissue ultrasonic surgical system
Curved Jaw Cordless Ultrasonic Dissector
Covidien LP
SCD7A48
In Commercial Distribution

  • 20884521794808 ()
  • 10884521794801 ()

  • Length: 48 Centimeter


  • Soft-tissue ultrasonic surgical system
Curved Jaw Cordless Ultrasonic Dissector
Covidien LP
SCD7A39
In Commercial Distribution

  • 20884521794792 ()
  • 10884521794795 ()

  • Length: 39 Centimeter


  • Soft-tissue ultrasonic surgical system
Curved Jaw Cordless Ultrasonic Dissector
Covidien LP
SCD7A26
In Commercial Distribution

  • 20884521794785 ()
  • 10884521794788 ()

  • Length: 26 Centimeter


  • Soft-tissue ultrasonic surgical system
Curved Jaw Cordless Ultrasonic Dissector
Covidien LP
SCD7A13
In Commercial Distribution

  • 20884521794778 ()
  • 10884521794771 ()

  • Length: 13 Centimeter


  • Soft-tissue ultrasonic surgical system
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