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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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The Integra Movement Great Toe System total arthroplasty is an anatomically designed, semi-constrained, two-piece device designed for resurfacing of the base of the 1st metatarso-phalangeal (MTP) joint. The device uses the metatarsal hemi arthroplasty device paired with a phalangeal base manufactured from titanium with a UHMWPE articulating surface insert. The phalangeal joint replacement device is intended for cemented use.
Ascension Orthopedics, Inc.
MGT89010PPT
In Commercial Distribution

  • 10381780119890 ()
  • M268MGT89010PPT1 ()

  • .606 in L x .463 in W x .354 in H; Size 10
MGT89010PPT

  • Partial metatarsophalangeal joint prosthesis
The NSS Military Field Stimulator (MFS) ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS MFS is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS MFS is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS MFS offers regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
KEY ELECTRONICS, INC.
MFS
In Commercial Distribution

  • B327NSS202 ()
  • B327NSS2022 ()
  • B327NSS2021 ()
01-1011-NSS/MFS

  • Acupuncture electrical stimulation system
The NSS Neurostim ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS Neurostim is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS Neurostim is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS Neurostim offers regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
KEY ELECTRONICS, INC.
Neurostim
In Commercial Distribution

  • B327NSS201 ()
  • B327NSS2012 ()
  • B327NSS2011 ()
01-1021

  • Acupuncture electrical stimulation system
PCP25
PREMIER BIOTECH, INC
PBCard-01-PCP
In Commercial Distribution

  • B313PBCARD01PCP1 ()
  • B313PBCARD01PCP0 ()
PBCard-01-PCP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Single Dip Cassette Drug Test, PCP
Express Diagnostic Int'l, Inc.
30180C
In Commercial Distribution

  • B29830180C10 ()
30180C

  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
Single Dip Cassette Drug Test, PCP
EXPRESS DIAGNOSTICS INT'L, INC.
30180C
Not in Commercial Distribution

  • B29830180C0 ()
30180C

  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
Single Dip Drug Test, PCP
Express Diagnostic Int'l, Inc.
30180
In Commercial Distribution

  • B2983018010 ()
30180

  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
Single Dip Drug Test, PCP
EXPRESS DIAGNOSTICS INT'L, INC.
30180
Not in Commercial Distribution

  • B298301800 ()
30180

  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
Ora-GUARD is an OTC device worn on the teeth while sleeping, intended to protect the teeth and reduce damage caused by bruxing or nighttime grinding and prevention of the noise associated with bruxing and grinding.
Doc Brands, Inc.
1
In Commercial Distribution

  • 00816161015131 ()


  • Removable dental occlusal splint, customizable
The KGTI phalangeal component is fixed by means of a stem, which is inserted into the medullary canal of the phalanx. The implant is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.
Ascension Orthopedics, Inc.
012016
Not in Commercial Distribution

  • M2480120161 ()
  • 10381780065487 ()

  • .816 in dia x .662 in L; Size 3
012016

  • Partial metatarsophalangeal joint prosthesis
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