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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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SA Repl. Cvr. (1Hr) 10-Pk, VelaShape II
SYNERON MEDICAL LTD
KT71751
Not in Commercial Distribution

  • 37290109950359 ()
KT71751

  • Multi-modality skin contouring system
STOP X MODEL STOP U PACKED GRADIENT RED USA
POLLOGEN LTD
STOP U
In Commercial Distribution

  • 07290018007686 ()
34300010GR-US

  • Multi-modality skin contouring system
The ENDYMED PURE DentA is a device intended for use in Dermatologic and General Surgical Procedures.
ENDYMED MEDICAL LTD
PURE DentA 110V
In Commercial Distribution

  • 07290016814668 ()
ND_PRD00480-00

  • Multi-modality skin contouring system
The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator for delivery of non-thermal RF combined with massage: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite.
ENDYMED MEDICAL LTD
Contour MAX Handpiece
Not in Commercial Distribution

  • 07290016814477 ()
ND_PRD00467-00

  • Multi-modality skin contouring system
The handpiece is used as an accessory to EndyMed PRO MAX system, which is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The handpiece is indicated for mild to moderate facial wrinkles and rhytides.
ENDYMED MEDICAL LTD
Mini Shaper MAX Handpiece
Not in Commercial Distribution

  • 07290016814460 ()
ND_PRD00468-00

  • Multi-modality skin contouring system
The EndyMed Pro System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non- invasive treatment of mild to moderate facial wrinkles and rhytides
ENDYMED MEDICAL LTD
PRO 85W System Body 2200V
Not in Commercial Distribution

  • 07290016814194 ()
ND_PRD00009_F_B

  • Multi-modality skin contouring system
The EndyMed Pro System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non- invasive treatment of mild to moderate facial wrinkles and rhytides
ENDYMED MEDICAL LTD
PRO 85W System 220V
Not in Commercial Distribution

  • 07290016814187 ()
ND_PRD00009_F

  • Multi-modality skin contouring system
The EndyMed Pro System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non- invasive treatment of mild to moderate facial wrinkles and rhytides
ENDYMED MEDICAL LTD
PRO 85W System Face 110V
In Commercial Distribution

  • 07290016814170 ()
ND_PRD00006_F_F

  • Multi-modality skin contouring system
The EndyMed Pro System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non- invasive treatment of mild to moderate facial wrinkles and rhytides
ENDYMED MEDICAL LTD
PRO 85W System Body 110V
In Commercial Distribution

  • 07290016814163 ()
ND_PRD00006_F_B

  • Multi-modality skin contouring system
The EndyMed Pro System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non- invasive treatment of mild to moderate facial wrinkles and rhytides
ENDYMED MEDICAL LTD
PRO 85W System 110V
In Commercial Distribution

  • 07290016814156 ()
ND_PRD00006_F

  • Multi-modality skin contouring system
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