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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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Neck Comforter This product is used for the peripheral fixation of the neck and the longitudinal traction of the cervical vertebra.It is composed by cloth sleeves, three TPU round air bags and inflatable balls.It is mainly through stretching the cervical interspace under the inflatable state, reducing the pressure of the cervical interspace, improving the burden of the ligaments around the cervical vertebra, so that the injured cervical vertebra can get a full rest.
Guangzhou Xinbo Electronic Co., Ltd.
XB-JT1000
In Commercial Distribution

  • 06970742221497 ()


  • Wearable cervical spine traction device
Kit Includes: (T009D-L) D-Series FlipTop™ Cassette - LiftOut Rack 9 (R138) Montana Jack® (R166) 5 Explorer (R245) Cone Socket Mirror Handle (R375) Mixing Spatula-Applicator (T042) Meriam Tweezers (T046) Miller Articulating Paper Forceps (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium
PDT, INC.
R933 PDT Cement (Crown Seating) Kit
In Commercial Distribution

  • 00813677024947 ()
R933

  • Dental mirror, reusable
  • Instrument tray, reusable
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle
  • Dental spatula, reusable
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental irrigation/aspiration syringe
Kit Includes: T009D-F FlipTop™ Cassette 'D' - Fixed Rack 9 R245 Mirror Handle (Cone-Socket) T050 #5 Front Surface Mirror, Cone-Socket, (15/16') R166 Explorer 5 R138R Montana Jack® Rigid R375 Mixing Spatula/Applicator T046 Articulating paper forceps MILLER T235 Aspirating Anesthetic Syringe Medium T040 Tweezers COLLEGE T319 Bur Block
PDT, INC.
R981 Cement Kit
In Commercial Distribution

  • 00813677024473 ()
R981

  • Dental mirror, reusable
  • Instrument tray, reusable
  • Manual dental scaler, reusable
  • Dental surgical probe, reusable
  • Manual non-rotary dental instrument handle
  • Dental spatula, reusable
  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
  • Dental irrigation/aspiration syringe
The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG(3-lead, 5-lead, 12-lead selectable), arrhythmia detection, ST segment analysis, Heart Rate(HR), Respiration Rate(RESP), Temperature(TEMP), Pulse Oxygen Saturation(Masimo-SpO2), Pulse Rate(PR), Non-invasive Blood Pressure(NIBP), Invasive Blood Pressure(IBP), Carbon dioxide(CO2), Anesthetic Gas(AG), Impedance Cardiograph(ICG), Cerebral State Index(CSI), Bispectral Index(BIS), Total Hemoglobin(SpHb), Carboxyhemoglobin(SpCO), and Methemoglobin(SpMet).
Guangdong Biolight Meditech Co., Ltd.
Q5
In Commercial Distribution

  • 06932562310096 ()


  • General-purpose multi-parameter bedside monitor
The revogene Strep A assay, performed on the revogene instrument, is an automated, qualitative in vitro diagnostic test that utilizes real-time polymerase chain reaction (PCR) for the direct detection of Streptococcus pyogenes (Group A B-hemolytic Streptococcus) nucleic acids from throat swab specimens. The revogene Strep A assay is intended for use as an aid in the diagnosis of the Group A Streptococcus infection. The revogene Strep A assay is intended for use in hospital, reference or state laboratory settings.
MERIDIAN BIOSCIENCE, INC.
410400
In Commercial Distribution

  • 00840733102325 ()


  • Beta-haemolytic Group A Streptococcus nucleic acid IVD, kit, nucleic acid technique (NAT)
The Integra OS Osteoconductive Scaffold - Moldable Morsels are a resorbable bone void filler made from a porous highly purified microfibrillar collagen combined with high purity tricalcium phosphate (TCP) granules and cubes. The implant is designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. It quickly imbibes fluids, making it easy to combine with bone marrow aspirate.
Integra Lifesciences Corporation
IOSMM030
Not in Commercial Distribution

  • 10381780071150 ()
  • M269IOSMM0301 ()

  • 3cc
IOSMM030

  • Bone matrix implant, composite
The Integra OS Osteoconductive Scaffold - Moldable Morsels are a resorbable bone void filler made from a porous highly purified microfibrillar collagen combined with high purity tricalcium phosphate (TCP) granules and cubes. The implant is designed to facilitate the repair of bony defects. In the dry state, the matrix has a three dimensional trabecular network of pores that resembles the pore structure of human cancellous bone. It quickly imbibes fluids, making it easy to combine with bone marrow aspirate.
Integra Lifesciences Corporation
IOSMM015
Not in Commercial Distribution

  • 10381780071143 ()
  • M269IOSMM0151 ()

  • 1.5cc
IOSMM015

  • Bone matrix implant, composite
The AXUS ES-5 is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the state. The AXUS ES-5 is a battery operated prescription use only electro-acupuncture device used for applying electric stimuli to areas of preferred delivery (APD). The device uses a low-intensity, low-frequency pulse multimode generator through micro-alligator clips attached to commercially available and FDA-cleared stainless steel acupuncture needles. The device can also deliver stimulation with the included probe.
TENS PLUS INDUSTRIAL COMPANY
ED3930
In Commercial Distribution

  • 14897076720092 ()
ED3930

  • Analgesic transcutaneous electrical nerve stimulation system
Kit Includes: (T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R245) Cone Socket Mirror Handle (R311) DG 16 Explorer (R312) D11 Endo Spreader (R314) 1-3 Endo Plugger (R315) 5-7 Endo Plugger (R316) 9-11 Endo Plugger (R317) Glick 1 (R318) 31L Endo Excavator (T046) Miller Articulating Paper Forceps (T047) Endo Locking Pliers (T050) #5 Mirror (15/16") (T235) Aspirating Anesthetic Syringe Medium (T784) Ainsworth Rubber Dam Punch Forceps (T785) Ivory Rubber Dam Clamp Forceps (T786) Rubber Dam Frame (T863) Small Parts Basket
PDT, INC.
R943 PDT Endo Kit
In Commercial Distribution

  • 00813677024985 ()
R943

  • Dental mirror, reusable
  • Manual non-rotary dental instrument handle
  • Instrument tray, reusable
  • Dental surgical probe, reusable
  • Manual endodontic filling material spreader
  • Endodontic plugger
  • Dental excavator, reusable
  • Dental irrigation/aspiration syringe
  • Rubber dam punch
  • Rubber dam clamp forceps
  • Rubber dam frame
Curaplex Automated External Defibrillator (AED) Kit in Yellow Pouch
BOUND TREE MEDICAL, LLC
651777
In Commercial Distribution

  • 00815277021210 ()
  • 00810071639272 ()
651777

  • Nitrile examination/treatment glove, non-powdered, antimicrobial
  • Safety razor, single-use
  • Antiseptic skin towelette
  • Cardiopulmonary resuscitation mask, single-use
  • Dry medical towel/wipe, single-use
  • Bandage scissors, reusable
  • Laboratory waste receptacle IVD
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