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. Small Cvr. 10x13mm (4 Hr) 5-Pk, Velashape III
SYNERON MEDICAL LTD
KT75061
Not in Commercial Distribution

  • 17290109950416 ()
KT75061

  • Multi-modality skin contouring system
SA Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III
SYNERON MEDICAL LTD
AS8334A
Not in Commercial Distribution

  • 07290109950808 ()
  • 37290109950809 ()
  • 17290109950805 ()
AS8334A

  • Multi-modality skin contouring system
Repl. Cover (Dark Gray), SA-8Hr, VelaShape II
SYNERON MEDICAL LTD
AS81221
Not in Commercial Distribution

  • 07290109950761 ()
  • 37290109950762 ()
  • 17290109950768 ()
AS81221

  • Multi-modality skin contouring system
Repl. Cover,(White) LA-8Hr, Vela Shape II
SYNERON MEDICAL LTD
AS77802
Not in Commercial Distribution

  • 07290109950723 ()
  • 37290109950724 ()
  • 17290109950720 ()
AS77802

  • Multi-modality skin contouring system
Repl. Cover,(Dark Gray) LA-24Hr, VelaSmooth Pro
SYNERON MEDICAL LTD
AS80242
Not in Commercial Distribution

  • 07290109950594 ()
  • 17290109950591 ()
AS80242

  • Multi-modality skin contouring system
Repl. Cover, SA-4Hr, VelasmoothPro
SYNERON MEDICAL LTD
AS75402
Not in Commercial Distribution

  • 07290109950587 ()
  • 17290109950584 ()
AS75402

  • Multi-modality skin contouring system
Repl. Cover (Grey), SA-1Hr, VelaShape II
SYNERON MEDICAL LTD
AS74672
Not in Commercial Distribution

  • 07290109950358 ()
AS74672

  • Multi-modality skin contouring system
Repl. Cover (Grey), LA-1Hr, VelaShape II
SYNERON MEDICAL LTD
AS74686
Not in Commercial Distribution

  • 07290109950341 ()
AS74686

  • Multi-modality skin contouring system
Vela Shape II System 100V, Packaged
SYNERON MEDICAL LTD
FG70331
Not in Commercial Distribution

  • 07290109950310 ()
FG70331

  • Multi-modality skin contouring system
Vela Shape II System 115V, Packaged
SYNERON MEDICAL LTD
FG70321
Not in Commercial Distribution

  • 07290109950303 ()
FG70321

  • Multi-modality skin contouring system
VelaShape System 100V, Packaged
SYNERON MEDICAL LTD
FG00131
Not in Commercial Distribution

  • 07290109950242 ()
FG00131

  • Multi-modality skin contouring system
Repl. Cover (Dark Gray), SA-12Hr, VelaSmooth Pro
SYNERON MEDICAL LTD
AS80251
Not in Commercial Distribution

  • 07290109950600 ()
  • 17290109950607 ()
AS80251

  • Multi-modality skin contouring system
Repl. Cover, LA-16Hr, VelasmoothPro
SYNERON MEDICAL LTD
AS75394
Not in Commercial Distribution

  • 07290109950570 ()
  • 17290109950577 ()
AS75394

  • Multi-modality skin contouring system
VelasmoothPro System 115V, Packaged
SYNERON MEDICAL LTD
FG70261
Not in Commercial Distribution

  • 07290109950549 ()
FG70261

  • Multi-modality skin contouring system
VelasmoothPro System 100V, Packaged
SYNERON MEDICAL LTD
FG70271
Not in Commercial Distribution

  • 07290109950532 ()
FG70271

  • Multi-modality skin contouring system
Vela- Pack. 115Vac Assy
SYNERON MEDICAL LTD
AS20341
Not in Commercial Distribution

  • 07290109950471 ()
AS20341

  • Multi-modality skin contouring system
Vela- Pack.100Vac Assy
SYNERON MEDICAL LTD
AS24021
Not in Commercial Distribution

  • 07290109950464 ()
AS24021

  • Multi-modality skin contouring system
Repl. Cover (cream), SA-4Hr, VelaShape II
SYNERON MEDICAL LTD
AS77813
Not in Commercial Distribution

  • 07290109950440 ()
  • 37290109950441 ()
  • 17290109950447 ()
AS77813

  • Multi-modality skin contouring system
SA Med. Repl. Cover 25x30mm, 4Hr, Velashape III
SYNERON MEDICAL LTD
AS83332
Not in Commercial Distribution

  • 07290109950433 ()
AS83332

  • Multi-modality skin contouring system
SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III
SYNERON MEDICAL LTD
AS87511
Not in Commercial Distribution

  • 07290109950426 ()
AS87511

  • Multi-modality skin contouring system
SA Small Repl. Cover 10x13mm, 4Hr, Velashape III
SYNERON MEDICAL LTD
AS83322
Not in Commercial Distribution

  • 07290109950419 ()
AS83322

  • Multi-modality skin contouring system
SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III
SYNERON MEDICAL LTD
AS87512
Not in Commercial Distribution

  • 07290109952703 ()
  • 17290109952700 ()
AS87512

  • Multi-modality skin contouring system
SA Med. Repl. Cover 25x30mm, 4Hr, Velashape III
SYNERON MEDICAL LTD
AS83333
Not in Commercial Distribution

  • 17290109952694 ()
  • 07290109952697 ()
AS83333

  • Multi-modality skin contouring system
VelaShape III System 120V, Packaged
SYNERON MEDICAL LTD
FG71201R
Not in Commercial Distribution

  • 07290109952437 ()
FG71201R

  • Multi-modality skin contouring system
Replaceable Cover, Vsmooth 4Hr, Velashape III
SYNERON MEDICAL LTD
AS85993
Not in Commercial Distribution

  • 07290109952215 ()
AS85993

  • Multi-modality skin contouring system
Repl. Cover,(White) LA-16Hr, Stacking, Vela Shape II
SYNERON MEDICAL LTD
AS85392
Not in Commercial Distribution

  • 07290109952161 ()
AS85392

  • Multi-modality skin contouring system
Repl. Cover,(White) LA-8Hr, Stacking, Vela Shape II
SYNERON MEDICAL LTD
AS85352
Not in Commercial Distribution

  • 07290109952154 ()
AS85352

  • Multi-modality skin contouring system
VelaShape III System 120V, Packaged
SYNERON MEDICAL LTD
FG71201
Not in Commercial Distribution

  • 07290109952031 ()
FG71201

  • Multi-modality skin contouring system
VelaShape III System 100V, Packaged
SYNERON MEDICAL LTD
FG71211
Not in Commercial Distribution

  • 07290109952024 ()
FG71211

  • Multi-modality skin contouring system
Vela Shape II System 100V, Packaged
SYNERON MEDICAL LTD
FG70331R
Not in Commercial Distribution

  • 07290109951546 ()
FG70331R

  • Multi-modality skin contouring system
Vela Shape II System 115V, Packaged
SYNERON MEDICAL LTD
FG70321R
Not in Commercial Distribution

  • 07290109951539 ()
FG70321R

  • Multi-modality skin contouring system
VelasmoothPro System 100V, Packaged
SYNERON MEDICAL LTD
FG70271R
Not in Commercial Distribution

  • 07290109951508 ()
FG70271R

  • Multi-modality skin contouring system
VelasmoothPro System 115V, Packaged
SYNERON MEDICAL LTD
FG70261R
Not in Commercial Distribution

  • 07290109951492 ()
FG70261R

  • Multi-modality skin contouring system
VelaShape System 100V, Packaged
SYNERON MEDICAL LTD
FG00131R
Not in Commercial Distribution

  • 07290109951447 ()
FG00131R

  • Multi-modality skin contouring system
Vela SA Appl.Pack.+ Disp.Parts for Appl.
SYNERON MEDICAL LTD
AS38211R
Not in Commercial Distribution

  • 07290109951348 ()
AS38211R

  • Multi-modality skin contouring system
Refurbished ,Vela- Pack.100Vac Assy
SYNERON MEDICAL LTD
AS24021R
Not in Commercial Distribution

  • 07290109951317 ()
AS24021R

  • Multi-modality skin contouring system
Refurbished ,Vela- Pack. 115Vac Assy
SYNERON MEDICAL LTD
AS20341R
Not in Commercial Distribution

  • 07290109951294 ()
AS20341R

  • Multi-modality skin contouring system
STOP X MODEL STOP U PACKED R.G-CHRM USA
POLLOGEN LTD
Model U
In Commercial Distribution

  • 07290018007303 ()
34300010RP-US

  • Multi-modality skin contouring system
The EndyMed Newa is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults woman who have Fitzpatrick skin types I-IV.
ENDYMED MEDICAL LTD
1.5, Ivory demo
Not in Commercial Distribution

  • 17290014660455 ()
  • 07290014660458 ()
ND_PRD00200

  • Multi-modality skin contouring system
Sterile foam tipped applicator; 6-inch swab
Super Brush, LLC
53-4582-DS
In Commercial Distribution

  • 00603266535820 ()
  • 10603266535827 ()


  • General-purpose absorbent tip applicator/swab, single-use
Sterile foam tipped applicator; 6-inch swab
Super Brush, LLC
53-4582-TFS
In Commercial Distribution

  • 10603266534875 ()
  • 00603266534878 ()


  • General-purpose absorbent tip applicator/swab, single-use
Sterile foam tipped applicator; 3-inch swab
Super Brush, LLC
53-1195-DS
In Commercial Distribution

  • 00603266531952 ()
  • 10603266531959 ()
  • 30603266531953 ()


  • General-purpose absorbent tip applicator/swab, single-use
Sterile foam tipped applicator; 3-inch swab
Super Brush, LLC
53-1195-TFS
In Commercial Distribution

  • 10603266531874 ()
  • 00603266531877 ()
  • 00603266531815 ()


  • General-purpose absorbent tip applicator/swab, single-use
Cotton Applicator, Triangular Tip, 6” (12.7cm)
ELMED INCORPORATED
ST365632
In Commercial Distribution

  • 00198506073274 ()
ST365632

  • ENT surgical procedure kit, non-medicated, reusable
Cotton Tipped applicator 6" small tip.
Bright Supply, Inc.
BSI-0006
In Commercial Distribution

  • D974BSI00062 ()
  • D974BSI00060 ()
  • D974BSI00061 ()
  • D974BSI00063 ()


  • General-purpose absorbent tip applicator/swab, single-use
Cotton Tipped applicator 3" small tip.
Bright Supply, Inc.
BSI-0003
In Commercial Distribution

  • D974BSI00032 ()
  • D974BSI00031 ()
  • D974BSI00030 ()
  • D974BSI00033 ()


  • General-purpose absorbent tip applicator/swab, single-use
Transwab Nasopharyngeal Charcoal Flexible Wire Applicator
MEDICAL WIRE & EQUIPMENT CO.(BATH)LIMITED
Charcoal
In Commercial Distribution

  • 25060259070123 ()
  • 05060259070129 ()
MW173C

  • General specimen collection kit IVD, clinical
Reusable Filshie Clip Applicator for minilaparotomy
FEMCARE LIMITED
AVM-856
Not in Commercial Distribution

  • 05055515602169 ()
AVM-856

  • Fallopian tube clip/band
IV START KIT W/ CHLORAPREP APPLICATOR
MEDLINE INDUSTRIES, INC.
DYNDV2408
In Commercial Distribution

  • 20193489197577 ()
  • 10193489197570 ()
DYNDV2408

  • Peripheral intravenous catheterization support kit
6" Cotton Tip Applicator, Sterile, 2-Pack
DYAD MEDICAL SOURCING, LLC
HCS1002
In Commercial Distribution

  • 10849027002058 ()
  • 00849027002051 ()
  • 20849027002055 ()


  • General-purpose absorbent tip applicator/swab, single-use
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