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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Reverse Lip ASA Rigid 20mmx120
THOMPSON SURGICAL INSTRUMENTS, INC.
SL6687
In Commercial Distribution

  • 00841536141382 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Rigid 25x152mm
THOMPSON SURGICAL INSTRUMENTS, INC.
6621
In Commercial Distribution

  • 00841536140033 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Tapered 25x225mm
THOMPSON SURGICAL INSTRUMENTS, INC.
6595
In Commercial Distribution

  • 00841536139914 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Tapered 25x100mm
THOMPSON SURGICAL INSTRUMENTS, INC.
6594
In Commercial Distribution

  • 00841536139907 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Malleable 25mm
THOMPSON SURGICAL INSTRUMENTS, INC.
6429
In Commercial Distribution

  • 00841536139273 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Tapered 25x120mm
THOMPSON SURGICAL INSTRUMENTS, INC.
6417
In Commercial Distribution

  • 00841536139167 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Rigid 32x120mm
THOMPSON SURGICAL INSTRUMENTS, INC.
5883
In Commercial Distribution

  • 00841536135381 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Rigid 32x175mm
THOMPSON SURGICAL INSTRUMENTS, INC.
5862
In Commercial Distribution

  • 00841536135336 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Rigid 32x175mm
THOMPSON SURGICAL INSTRUMENTS, INC.
5804
In Commercial Distribution

  • 00841536135053 ()


  • Surgical retraction system, reusable
Reverse Lip ASA Malleable 25mm
THOMPSON SURGICAL INSTRUMENTS, INC.
5868
In Commercial Distribution

  • 00841536128376 ()


  • Surgical retraction system, reusable
SnugFit ASA Size1 1xTape Short
Medacta International SA
05.11.070
In Commercial Distribution

  • 07630542778858 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
SnugFit ASA Size1 1xTape Long
Medacta International SA
05.11.071
In Commercial Distribution

  • 07630542778865 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
Assure paste is intended for use as light cure, hydrophilic bracket adhesive, therefore it can be applied to a dry or slightly contaminated surface. The smooth cohesive paste viscosity allows for easy application to any style bracket base insuring maximum mechanical retention.
RELIANCE ORTHODONTIC PRODUCTS INC
APP
In Commercial Distribution

  • D798APP0 ()
APP

  • Orthodontic bracket adhesive
The Lumolaser is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions. The device performs short term, non-invasive treatment, based on the irradiation of the skin with infrared wavelengths. The intended use of the device is to provide topical heating for the purpose of elevating tissue temperature for temporary relief of: muscle pain or muscle spasms, joint pain and stiffness, arthritis pain, minor sprains and strains, minor muscular back pain and temporary increase in local blood circulation promoting relaxation of muscle.
ASA SRL
F9000321
In Commercial Distribution

  • 08033765391764 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
The HIRO TT US is an electrically-powered Nd:YAG laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions. The device performs short term, non-invasive treatment, based on the irradiation of the skin with infrared wavelengths. The intended use of the device is to provide topical heating for the purpose of elevating tissue temperature for temporary relief of: muscle pain or muscle spasms, joint pain and stiffness, arthritis pain, minor sprains and strains, minor muscular back pain and temporary increase in local blood circulation promoting relaxation of muscle.
ASA SRL
F9000314
In Commercial Distribution

  • 08033765391757 ()
F9000314

  • Musculoskeletal infrared phototherapy unit, non-wearable
The M-Hi D US is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions. The device performs short term, non-invasive treatment, based on the irradiation of the skin with infrared wavelengths. The intended use of the device is to provide topical heating for the purpose of elevating tissue temperature for temporary relief of: muscle pain or muscle spasms, joint pain and stiffness, arthritis pain, minor sprains and strains, minor muscular back pain and temporary increase in local blood circulation promoting relaxation of muscle.
ASA SRL
F9000303
In Commercial Distribution

  • 08033765391740 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
The MiS US is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions. The device performs short term, non-invasive treatment, based on the irradiation of the skin with infrared wavelengths. The intended use of the device is to provide topical heating for the purpose of elevating tissue temperature for temporary relief of: muscle pain or muscle spasms, joint pain and stiffness, arthritis pain, minor sprains and strains, minor muscular back pain and temporary increase in local blood circulation promoting relaxation of muscle.
ASA SRL
F9000297
In Commercial Distribution

  • 08033765391726 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
The M-Hi US is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions. The device performs short term, non-invasive treatment, based on the irradiation of the skin with infrared wavelengths. The intended use of the device is to provide topical heating for the purpose of elevating tissue temperature for temporary relief of: muscle pain or muscle spasms, joint pain and stiffness, arthritis pain, minor sprains and strains, minor muscular back pain and temporary increase in local blood circulation promoting relaxation of muscle.
ASA SRL
F9000296
In Commercial Distribution

  • 08033765391702 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
The M7 is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions. The device performs short term, non-invasive treatment, based on the irradiation of the skin with infrared wavelengths. The intended use of the device is to provide topical heating for the purpose of elevating tissue temperature for temporary relief of: muscle pain or muscle spasms, joint pain and stiffness, arthritis pain, minor sprains and strains, minor muscular back pain and temporary increase in local blood circulation promoting relaxation of muscle.
ASA SRL
F9000290
In Commercial Distribution

  • 08033765391689 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
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
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